Clinical trial NCT03238781
Conditions: Chronic Migraine or Episodic Migraine
Keywords: Migraine Headache Prevention Prophylaxis
Sponsor: Amgen
Start date: 2017-09-06; Completion date: 2019-02-04
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

Detailed description:
A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.

Arms: arm 1: Participants randomized to Placebo were administered 6 subcutaneous (SC) injections on day 1 and weeks 2, 4, 6, 8 and 10 during the 12 week double-blind treatment period. arm 2: Participants randomized to AMG 301 210 mg every fourth week (Q4W) received a total of 3 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) plus 3 matching placebo injections on day 1 and weeks 4 and 8. Participants also received 6 SC placebo injections on weeks 2, 6, and 10 during the 12 week double-blind treatment period. arm 3: Participants randomized to AMG 301 420 mg every second week (Q2W) received a total of 6 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) on day 1 and weeks 2, 4, 6, 8, and 10 during the 12 week double-blind treatment period.
Interventions: intervention 1: Placebo intervention 2: AMG 301
Intervention descriptions: intervention 1: Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days. intervention 2: AMG 301 was packaged in 5 mL clear glass vials containing 1 mL of 70 mg/mL of AMG 301. All injections were administered within 30 minutes on treatment days.

Protocol documents:
Prot_000.pdf: 
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NCT Number: 03238781
This NCT number has been applied to the document 
for purposes of posting on clinicaltrials.gov


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 1 of 20 
CONFIDENTIAL 
 
 
Amendment 2 
Protocol Title:  A Phase 2a Randomized Double-blind Placebo Controlled Study to 
Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention 
 
Amgen Protocol Number AMG 301 20150308 
EudraCT Number:  2017-000630-57 
NCT03238781 
Amendment Date:  17 October 2017 
Rationale: 
This protocol is being amended for the following reasons: 
• 
Update schedule of activities and footnotes to maintain consistency with the protocol. 
• 
Update the exclusion screening criterion to maintain accordance with the World 
Health Organization’s guidelines of assessing impaired glucose regulation/ 
prediabetes with glycosylated hemoglobin (HbA1c) values. 
• 
Make minor corrections and clarifications throughout the document, including 
administrative, typographical, and formatting errors. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 2 of 20 
CONFIDENTIAL 
 
 
Description of Changes: 
Section:  Global 
Change:  Update protocol amendment dates throughout document from 16 May 2017 to 
17 October 2017 
Section:  Global 
Change:  Editorial changes (including typographical, grammatical, and formatting) have 
been made throughout the document. 
Section:  Title page 
Replace: 
NCT Number: 
Not applicable 
With: 
NCT Number: 
NCT03238781 
Section:  Title page 
Add: 
Protocol Date: 
Document Version 
Date 
Original 
16 March 2017 
Amendment 1 
16 May 2017 
Amendment 2 
17 October 2017 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 3 of 20 
CONFIDENTIAL 
 
 
Section:  2.2.  Schedule of Activities, Table 2-1 
Replace: 
Procedure 
Screening Period 
(Up to 7 weeks) 
Double-Blind Treatment Perioda 
(12 weeks) (± 2 days) 
Safety Follow-up Period 
(16 weeks) (± 5 days) 
Screening 
up to 3 
weeks 
Baseline Periodb 
Day 1 
(Post-
rand)c 
Wk 1 Wk 2 Wk 4 Wk 6 Wk 8 Wk 9 Wk 10 
Wk  
12/ETd Wk 16 
Wk  
20 
Wk  
24 
Wk 28/ET/ 
EOSd 
-4 
Weeks 
Pre-rand 
(Day 1) 
Vital signsg 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Concomitant medications 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hepatitis B and Hepatitis 
C storage sample 
 
 
Xp 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fasting plasma glucose 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PK Samplingm 
 
 
 
X 
X 
 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
Anti-AMG 301 antibodies 
(serum) 
 
 
 
X 
 
 
 
 
X 
 
 
X 
X 
 
X 
X 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 4 of 20 
CONFIDENTIAL 
 
 
With:   
Procedure 
Screening Period 
(Up to 7 weeks) 
Double-Blind Treatment Perioda 
(12 weeks) (± 2 days) 
Safety Follow-up Period 
(16 weeks) (± 5 days) 
Screening  
up to 3 
weeks 
Baseline Periodb 
Day 1 
(Post-
rand)c 
Wk 1 Wk 2 Wk 4 Wk 6 Wk 8 Wk 9 Wk 10 
Wk  
12/ETd Wk 16 
Wk  
20 
Wk  
24 
Wk 28/ET/ 
EOSd 
-4 
Weeks 
Pre-rand 
(Day 1) 
Vital signsg 
X 
X 
Xh 
Xi 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hepatitis B and Hepatitis 
C storage sample 
 
 
 
Xm 
 
 
 
 
 
 
 
 
 
 
 
 
Serum plasma glucosen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PK Sampling (serum)s 
 
 
 
X 
X 
 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
Anti-AMG 301 antibodies 
(serum)s 
 
 
 
X 
 
 
 
 
X 
 
 
X 
X 
 
X 
X 
Section:  2.2.  Schedule of Activities, Table 2.1, Footnotes h, i, and n 
Add:  
h. 
Vital signs will be assessed prior to subject registration using the IVR/IWR system. 
i. 
Vital signs will be assessed approximately 30 to 60 minutes after investigational product administration. 
n. 
Sites are encouraged to obtain a fasting glucose sample, if possible. 
Section:  2.2.  Schedule of Activities, Table 2.1, Footnote g 
Replace:  
g  
Vital signs will include systolic/diastolic blood pressure, heart rate, respiratory rate, and body temperature.  Subject must be in a 
supine position in a rested and calm state for at least 5 minutes before blood pressure assessments are conducted.  If the subject 
is unable to be in the supine position, the subject should be in most recumbent position as possible.  The position selected for a 
subject should be the same that is used throughout the study. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 5 of 20 
CONFIDENTIAL 
 
 
With: 
g  
Vital signs will be assessed prior to investigational product administration, and will include systolic/diastolic blood 
pressure, heart rate, respiratory rate, and body temperature.  Subject must be in a supine position in a rested and calm state for 
at least 5 minutes before blood pressure assessments are conducted.  If the subject is unable to be in the supine position, the 
subject should be in most recumbent position as possible.  The position selected for a subject should be the same that is used 
throughout the study. 
Section:  2.2.  Schedule of Activities, Table 2.1, Footnote o (formally q and r) 
Replace:  
q. 
Fasting blood glucose will be assessed at next visit if a subject has an HbA1c ≥ 5.7% from week 6 and beyond. 
r. 
A fasting blood glucose will be performed in cases where a serum glucose is ≥ 200 or HgA1c is ≥ 5.7%. 
With: 
o. 
A fasting blood glucose will be performed at next visit in cases where a serum glucose is ≥ 200 mg/dL or HbA1c is ≥ 5.7%. 
Section:  2.2.  Schedule of Activities, Table 2.1, Footnote s (formally m) 
Replace: 
m. 
PK sampling will be serum and collected at predose on day 1 and weeks 4, 8, and 10, and at postdose in weeks 1, 9, 12, 16, 24, 
and 28 or EOS. 
With: 
s. 
PK samples will be collected at predose on day 1 and weeks 4, 8, and 10, and at postdose in weeks 1, 9, 12, 16, 24, and 28 or 
EOS.  On days that anti-AMG 301 antibodies are scheduled to be collected, they are to be collected following the 
predose/postdose PK sampling schedule. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 6 of 20 
CONFIDENTIAL 
 
 
Section:  2.2.  Schedule of Activities, Table 2.1, Footnote r (formally s) 
Replace: 
s. 
On days where the first and second dose are administered, study center staff are to observe the subject for at least 120 minutes 
after the last injection of investigational product.  On later days when dose is administered, study center staff will observe the subject for 
at least 60 minutes after the last injection of investigational product.  Investigators can retain subjects for longer if there is any sign of 
discomfort any time following AMG 301 administration. 
With: 
r. 
On day 1 post-randomization and week 2 visits, study center staff are to observe the subject for at least 120 minutes after the 
last injection of investigational product.  On weeks 4, 6, 8, and 10 visits, study center staff will observe the subject for at least 
60 minutes after the last injection of investigational product.  Investigators can retain subjects for longer if there is any sign of discomfort 
any time following AMG 301 administration. 
Section:  2.2.  Schedule of Activities, Table 2.1, Footnotes j and q (formally h and l) 
Delete: 
j. 
Medical history will include targeted cardiologic, neurologic, psychiatric, cardiovascular, and history of diabetes, including 
gestational diabetes and/or impaired glucose tolerance testing.  A history of participation in prior Amgen studies will be included.  
Medication history to include targeted prior migraine prophylactic treatment history within the 90 days before screening will be 
collected. 
q. 
Study centers are to call the IVR/IWR system for the following:  to enter the subject into the screening period, to randomize an 
eligible subject into the double blind treatment period, to re-randomize a subject into the double-blind treatment period, to obtain 
the investigational product assignment, to register the end of investigational product, and to register study ET or completion.  
Subject data will be collected in the IVR/IWR system including, but not limited to, CM versus EM, sex, and reason for screen fail 
(if applicable).  Study centers to access the IVR/IWR system to obtain the investigational product assignment at day 1, and 
weeks 2, 4, 8, and 10.   
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 7 of 20 
CONFIDENTIAL 
 
 
Section:  6.2  Exclusion Criteria Part 1 
Replace:  
211 
Glycosylated hemoglobin (HbA1c) ≥ 5.7% at screening   
212 
Impaired glucose metabolism: defined as plasma glucose (fasting or otherwise) 
≥ 100 mg/dL at screening 
220 
Evidence of drug or alcohol abuse or dependence within 12 months before 
screening, based on medical records, subject self-report, or positive urine drug 
test performed during screening (with the exception of prescribed medications 
such as opioids, barbiturates, or cannabinoids). 
225 
Subjects must have been free of medications listed in Section 7.1.7 for at least 
2 months before the start of the baseline period (at least 4 months before 
baseline for botulinum toxin [head and/or neck region] and mABs targeting 
CGRP). 
228 
Female subject of childbearing potential who is unwilling to use an acceptable 
method of effective contraception during treatment with AMG 301 through 
18 weeks after the last dose of investigational product.  Acceptable methods of 
effective birth control include not having intercourse (true abstinence, when this 
is in line with the preferred and usual lifestyle of the subject [periodic abstinence, 
eg, calendar, ovulation, symptothermal, post-ovulation methods], declaration of 
abstinence for the duration of a trial, and withdrawal are not acceptable methods 
of contraception), hormonal birth control methods (pills, shots/injections, implants 
or patches), intrauterine devices, surgical contraceptive methods (vasectomy 
with medical assessment of the surgical success of this procedure or bilateral 
tubal ligation), or 2 barrier methods (each partner must use one barrier method) 
with spermicide - males must use a condom with spermicide; females must 
choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR 
contraceptive sponge with spermicide. 
Female subjects not of childbearing potential are defined as any female who: 
• 
Is post-menopausal by history, defined as  
o Age > 55 years with cessation of menses for 12 or more months, 
OR 
o Age < 55 years and no spontaneous menses for at least 
12 months and with a follicle-stimulating hormone level > 40 IU/L 
or according to the definition of “postmenopausal range” for the 
laboratory involved  
OR 
• 
Underwent bilateral oophorectomy OR 
• 
Underwent bilateral salpingectomy OR 
• 
Underwent hysterectomy 
Refer to Appendix 5 for additional contraceptive information. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 8 of 20 
CONFIDENTIAL 
 
 
With: 
211 
Glycosylated hemoglobin (HbA1c) ≥ 6.0% at screening   
212 
Serum plasma glucose level ≥ 100 mg/dL at screening; ideally performed 
while fasting 
220 
Evidence of drug or alcohol abuse or dependence within 12 months before 
screening, based on medical records, subject self-report, or positive urine drug 
test performed during screening (with the exception of prescribed medications 
such as opioids, or barbiturates). 
225 
Subjects taking medications listed in Section 7.1.7 for at least 2 months before 
the start of the baseline period (at least 4 months before baseline for botulinum 
toxin [head and/or neck region] and mABs targeting CGRP). 
228 
Female subject of childbearing potential who is unwilling to use an acceptable 
method of effective contraception during treatment with AMG 301 through 
18 weeks after the last dose of investigational product. 
Refer to Appendix 5 for additional contraceptive information. 
Section:  6.4  Exclusion Criteria Part 2 
Delete:  
234. 
Used a prohibited medication, device or procedure before during the baseline 
period (Refer to Section 7.1.7 for the list of these excluded treatments and the 
timeframes)  
Section:  6.7.  Screen Failures, Paragraph 1 
Delete:  
Screen failures are defined as subjects who consent to participate in the clinical study 
but are not subsequently randomized in the study.  A minimal set of screen failure 
information will be collected that includes demography, screen failure details, eligibility 
criteria, medical history, prior therapies, Clinical Outcome Assessments (COAs), 
C-SSRS, BDI-II, laboratory assessments and any serious adverse events. 
Section:  7.1.3.  Medical Devices, Paragraph 1 
Replace: 
One mL sterile syringes will be used in this study. 
With: 
Sterile syringes will be used in this study.   
Section:  7.1.7.  Excluded Treatments, Medical Devices, and/or Procedures During 
Study Period, Bullet point 15 
Add:  
• 
cannabinoids 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 9 of 20 
CONFIDENTIAL 
 
 
Section:  9.2.1.8.1.  Cranial Autonomic Parasympathetic Symptom Scale 
Replace:  
The CAPS scale will be administered by clinical study center staff as described in 
Table 2-1. 
With:  
The CAPS scale will be administered by a clinician (ie, primary investigator or 
delegate) as described in Table 2-1. 
Section:  9.2.3.1.1.2.  Adverse Events, Paragraph 1 
Delete: 
Adverse Events will be reported from the first dose of investigational product through the 
EOS. 
Section:  9.2.3.1.1.3.  Serious Adverse Events, Paragraphs 1 and 2 (text rearranged) 
Replace: 
Serious Adverse Events will be collected from signing of Informed Consent Form 
through the end of the safety follow-up visit (18 weeks after last dose of investigational 
product or EOS).   
The investigator is responsible for ensuring that all serious adverse events observed by 
the investigator or reported by the subject that occur after signing of the informed 
consent through end of study are reported using the Event CRF. 
With: 
The investigator is responsible for ensuring that all serious adverse events observed by 
the investigator or reported by the subject that occur after signing of the informed 
consent through the end of the safety follow-up visit (18 weeks after last dose of 
investigational product or EOS) are reported using the Event CRF. 
Section:  9.2.3.3.  Electrocardiograms (ECGs), Paragraph 1, Sentence 6 
Delete: 
The primary investigator will review all ECGs.   


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 10 of 20 
CONFIDENTIAL 
 
 
Section:  Appendix 4.  Safety Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up and Reporting, Reporting of Serious Adverse Event, Figure 12-1 
Replace: 
Figure 12-1.  Sample Electronic Serious Adverse Event Report Form 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 11 of 20 
CONFIDENTIAL 
 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 12 of 20 
CONFIDENTIAL 
 
 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 13 of 20 
CONFIDENTIAL 
 
 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 14 of 20 
CONFIDENTIAL 
 
 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 15 of 20 
CONFIDENTIAL 
 
 
With: 
Figure 12-1.  Sample Electronic Serious Adverse Event Contingency Report Form 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 16 of 20 
CONFIDENTIAL 
 
 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 17 of 20 
CONFIDENTIAL 
 
 
 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 18 of 20 
CONFIDENTIAL 
 
 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 19 of 20 
CONFIDENTIAL 
 
 
 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  17 October 2017 
Page 20 of 20 
CONFIDENTIAL 
 
 
Section:  Appendix 5.  Contraceptive Guidance and Collection of Pregnancy and 
Lactation Information, Definition of Females of Childbearing Potential, Paragraph 2, 
Bullet point (level 1) 3 
Delete:  
• 
Postmenopausal female (refer to Exclusion Criteria 229 above) 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  16 May 2017 
Page 1 of 16 
Amendment 1 
Protocol Title:  A Phase 2a Randomized Double-blind Placebo Controlled Study to 
Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention 
 
Amgen Protocol Number 20150308 
EudraCT Number 2017-000630-57 
 
Amendment Date: 
16 May 2017 
Rationale: 
The original protocol was submitted to regulatory authorities in the EU via the Voluntary 
Harmonisation Procedure (VHP).  During review the VHP revisions were requested to 
the study protocol.  In addition, the Sponsor took the opportunity to make corrections 
and administrative updates.  
In addition, the following were clarified to ensure alignment with study procedures: 
• 
Clarify the number of subjects that will be screened and enter baseline in order to 
achieve the target randomization 
• 
Clarify when vital signs, pharmacokinetic sampling, and Headache Impact Test will 
be collected during the study 
• 
Clarify the risks and benefits of the study 
• 
Removal of legally acceptable representative from the study 
• 
Clarify that upon early discontinuation, a safety follow-up visit will be performed 
approximately 30 (± 5) days after the last dosing interval of investigation product 
• 
Add additional information for sample size calculation for each AMG 301 group 
versus placebo 
• 
Clarify that the primary analysis set is also known as the efficacy analysis set 
• 
Clarify which primary and secondary endpoints will be included in the interim 
analysis 
• 
Add the responsibilities of the Data Review Team during the double-blind treatment 
phase 
• 
Clarify Amgen’s regulatory responsibilities when an amendment is determined to 
substantial 
• 
Administrative, typographical, and formatting changes were made throughout the 
protocol 
CONFIDENTIAL 
 

SAP_001.pdf: 
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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 2 of 82 
 
 
CONFIDENTIAL 
 
Table of Contents 
Table of Contents .............................................................................................................. 2 
1. 
Introduction .............................................................................................................. 7 
2. 
Objectives, Endpoints and Hypotheses .................................................................... 8 
2.1 
Objectives and Endpoints ............................................................................. 8 
2.2 
Hypotheses and/or Estimations .................................................................. 11 
3. 
Study Overview ...................................................................................................... 13 
3.1 
Study Design .............................................................................................. 13 
3.2 
Sample Size ............................................................................................... 14 
3.3 
Adaptive Design ......................................................................................... 14 
4. 
Covariates and Subgroups ..................................................................................... 15 
4.1 
Planned Covariates .................................................................................... 15 
4.2 
Subgroups .................................................................................................. 15 
5. 
Definitions .............................................................................................................. 16 
5.1 
Endpoints .................................................................................................... 16 
5.1.1 
Efficacy Endpoints ...................................................................... 16 
5.1.2 
Safety Endpoints ........................................................................ 22 
5.2 
Study Dates ................................................................................................ 23 
5.3 
Study Points of Reference .......................................................................... 24 
5.4 
Study Time Intervals ................................................................................... 25 
5.5 
Subject Disposition ..................................................................................... 30 
5.6 
Arithmetic Calculations ............................................................................... 30 
5.7 
Disease Characteristics .............................................................................. 33 
6. 
Analysis Sets .......................................................................................................... 34 
6.1 
Full Analysis Set ......................................................................................... 34 
6.2 
Primary Analysis Set .................................................................................. 34 
6.3 
Safety Analysis Set ..................................................................................... 34 
6.4 
Pharmacokinetic/Pharmacodynamic Analyses Set(s) ................................ 34 
7. 
Planned Analyses .................................................................................................. 35 
7.1 
Interim Analysis and Early Stopping Guidelines ......................................... 35 
7.2 
Primary Analysis ......................................................................................... 36 
7.3 
Final Analysis ............................................................................................. 36 
8. 
Data Screening and Acceptance ............................................................................ 37 
8.1 
General Principles ...................................................................................... 37 
8.2 
Data Handling and Electronic Transfer of Data .......................................... 37 
8.3 
Handling of Missing and Incomplete Data .................................................. 37 
8.3.1 
Missing and Incomplete Dates ................................................... 38 
8.3.2 
Missing Baseline Evaluation ....................................................... 39 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 3 of 82 
 
 
CONFIDENTIAL 
 
8.3.3 
Missing Post-baseline Evaluation in the DBTP .......................... 39 
8.3.4 
Missing Safety-Follow up Period ................................................ 40 
8.4 
Detection of Bias ........................................................................................ 40 
8.5 
Outliers ....................................................................................................... 40 
8.6 
Distributional Characteristics ...................................................................... 41 
8.7 
Validation of Statistical Analyses ................................................................ 41 
9. 
Statistical Methods of Analysis ............................................................................... 42 
9.1 
General Considerations .............................................................................. 42 
9.2 
Subject Accountability ................................................................................ 43 
9.3 
Important Protocol Deviations .................................................................... 43 
9.4 
Demographic and Baseline Characteristics ................................................ 44 
9.5 
Efficacy Analyses ....................................................................................... 45 
9.5.1 
Analyses of Primary Efficacy Endpoint(s) ................................... 49 
9.5.2 
Analyses of Secondary Efficacy Endpoint(s) .............................. 51 
9.5.3 
Analyses of Exploratory Efficacy Endpoint(s) ............................. 51 
9.5.4 
Analyses of Clinical Outcome Assessments (COAs) 
and Patient Reported Outcomes (PROs) ................................... 52 
9.5.5 
Pharmacokinetic Endpoints ........................................................ 52 
9.6 
Safety Analyses .......................................................................................... 53 
9.6.1 
Analyses of Primary Safety Endpoint(s) ..................................... 53 
9.6.2 
Adverse Events and Disease-related Events ............................. 53 
9.6.3 
Laboratory Test Results ............................................................. 54 
9.6.4 
Vital Signs ................................................................................... 55 
9.6.5 
Beck Depression Inventory (BDI)-II ............................................ 55 
9.6.6 
Columbia Suicide Severity Rating Score (C-SSRS) ................... 55 
9.6.7 
Physical Measurements ............................................................. 55 
9.6.8 
Electrocardiogram ...................................................................... 55 
9.6.9 
Antibody Formation .................................................................... 56 
9.6.10 
Exposure to Investigational Product ........................................... 56 
9.6.11 
Exposure to Concomitant Medication ......................................... 56 
9.6.12 
Exposure to Prior Prophylactic Medication ................................. 56 
9.6.13 
Cardiovascular Medical History .................................................. 56 
9.6.14 
Cardiac and Diabetes Risk Factors ............................................ 56 
9.7 
Other Analyses ........................................................................................... 56 
9.7.1 
Analyses of Pharmacokinetic or 
Pharmacokinetic/Pharmacodynamic Endpoints ......................... 56 
9.7.2 
Analyses of Clinical Outcome Assessments .............................. 57 
10. 
Changes From Protocol-specified Analyses .......................................................... 58 
11. 
Literature Citations / References ............................................................................ 59 
12. 
Prioritization of Analyses ........................................................................................ 61 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 4 of 82 
 
 
CONFIDENTIAL 
 
13. 
Data Not Covered by This Plan .............................................................................. 62 
14. 
Appendices ............................................................................................................ 63 
List of Tables 
Table 5-1.  Monthly Interval for Efficacy Endpoints Derived From Daily eDiary 
Data ......................................................................................................... 26 
Table 5-2.  Study Visit Windows for HIT-6, MMIDAS, C-SSRS, and CAPS 
Scale ........................................................................................................ 27 
Table 5-3.  Study Visit Windows for Lab (Except HbA1C and Urinalysis) ....................... 27 
Table 5-4.  Study Visit Windows for HbA1C .................................................................... 27 
Table 5-5.  Study Visits for Vital Signs ............................................................................ 28 
Table 5-6.  Study Visits for Physical Examination ........................................................... 28 
Table 5-7.  Study Visits for PK ........................................................................................ 29 
Table 5-8.  Study Visits for Antibody ............................................................................... 29 
Table 8-1.  Handling of Missing and Incomplete eDiary Data ......................................... 38 
Table 9-1.  Summary of Efficacy Endpoints and Analysis Methods ................................ 46 
Table 9-2.  Summary of COA and PRO Endpoints and Analysis Methods ..................... 52 
Table 9-3.  Safety Endpoint Summary Table .................................................................. 53 
List of Appendices 
Appendix A.  Technical Detail and Information Regarding Statistical 
Procedures and Programming ................................................................. 64 
Appendix B.  Code Fragment .......................................................................................... 65 
Appendix C.  Reference Values/Toxicity Grades ............................................................ 71 
Appendix D.  Concomitant Medications .......................................................................... 72 
Appendix E.  Clinical Outcome Assessment Forms/Instruments .................................... 73 
Appendix F.  Health Economic Forms/Instruments ......................................................... 81 
Appendix G.  Details of PK or PK/PD Methods for Modeling .......................................... 82 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 5 of 82 
 
 
CONFIDENTIAL 
 
List of Abbreviations and Definition of Terms 
 
Abbreviation or Term 
Definition/Explanation 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
BDI-II 
Beck Depression Inventory - II 
BMI 
body mass index 
CAPS 
Cranial Autonomic Parasympathetic Symptom 
CGRP 
Calcitonin gene-related peptide 
CM 
chronic migraine 
COAs 
Clinical Outcome Assessments 
CRF 
case report form 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
CTCAE 
Common Terminology Criteria for Adverse Events 
DBTP 
Double-blind Treatment Period 
DRE 
Disease-Related Event 
EAS 
efficacy analysis set 
ECG 
electrocardiogram 
eDiary 
Electronic diary 
EM 
episodic migraine 
End of Study (end of trial) 
defined as the date when the last subject is assessed or 
receives an intervention for evaluation in the study (ie, last 
subject last visit), following any additional parts in the study 
(eg, long-term follow-up), as applicable 
End of Treatment 
defined as the last assessment for the protocol-specified 
treatment phase of the study for an individual subject 
Enrollment 
when the investigator decides that the subject has met all Part 
1 and Part 2 eligibility criteria 
EOS 
end of study 
ET 
Early termination 
FAS 
full analysis set 
HbA1c 
glycosylated hemoglobin 
HIT-6 
Headache Impact Test-6 
IC50 
half maximum inhibitory concentration 
ICH 
International Council for Harmonisation 
Page 1 of 2 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 6 of 82 
 
 
CONFIDENTIAL 
 
Abbreviation or Term 
Definition/Explanation 
ICHD 
International Classification of Headache Disorders 
ICHD-IIIb 
ICHD, third edition beta 
IV 
Intravenous 
IVR 
Interactive Voice Response 
IWR 
Interactive Web Response 
MedDRA 
Medical Dictionary for Regulatory Activities 
MIDAS 
Migraine Disability Assessment 
MPFID 
Migraine Physical Function Impact Diary 
MMPFID 
Modified Migraine Physical Function Impact Diary 
PACAP 
Pituitary adenylate cyclase-activating polypeptide 
PD 
pharmacodynamic 
PK 
Pharmacokinetics 
PRO 
patient-reported outcome 
Q2W 
every 2 weeks 
Q4W 
every 4 weeks 
Randomization 
A subject will be randomized to treatment assignment 
SAS 
safety analysis set 
SC 
Subcutaneous 
SSAP 
Supplement Statistical Analysis Plan 
Study Day 1 
defined as the first day that protocol-specified investigational 
product(s)/protocol-required therapies is/are administered to 
the subject 
TBL 
total bilirubin 
ULN 
upper limit of normal 
VIP 
vasoactive intestinal polypeptide 
Page 2 of 2 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 7 of 82 
 
 
CONFIDENTIAL 
 
1. 
Introduction 
The purpose of this Statistical Analysis Plan (SAP) is to provide details of the statistical 
analyses that have been outlined within the protocol amendment 2 for Study 20150308, 
AMG 301 dated 17 October 2017. The scope of this plan includes the primary analysis 
and the final analysis that are planned and will be executed by the Amgen Global 
Biostatistical Science department unless otherwise specified. Full details of the 
independent, unblinded interim analyses are described in a separate Supplemental 
Statistical Analysis Plan (SSAP) and the Interim Analysis Review Steering Committee 
(IARSC) charter. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 8 of 82 
 
 
CONFIDENTIAL 
 
2. 
Objectives, Endpoints and Hypotheses 
2.1 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
 
To evaluate the effect of AMG 301 
compared to placebo on the change 
from the baseline period in monthly 
migraine days in subjects with 
migraine 
 
Change from the baseline period in 
monthly migraine days.  The monthly 
migraine days will be calculated using the 
migraine days over the last 4 weeks of the 
12‑week double‑blind treatment period 
The primary estimand consists of: 
 
The target population, which is patients with chronic or episodic migraine who 
have failed at least one prophylactic treatment for migraine 
 
The variable, which is the change in monthly migraine days from the baseline period 
over the last 4 weeks of the 12-week double-blind treatment period 
 
The population-level summary measure, which is the difference in the mean of the 
variable between each AMG 301 treatment group and the placebo group 
 
The intercurrent event, adherence to treatment will be ignored and the primary 
endpoint will be assessed for all subjects who receive at least 1 dose of 
investigation product and have at least 1 postbaline mothly eDiary measurement 
regardless of adherence to treatment 
The primary estimand is the difference in means between each AMG 301 treatment 
group and placebo in the change in monthly migraine days from the baseline period 
over the last 4 weeks of the 12-week double-blind treatment period for patients with 
chronic or episodic migraine who have failed at least one prophylactic treatment for 
migraine who are randomised, receive at least one dose of investigation product and 
have at least 1 post baseline mothly eDiary measurement. 
Secondary 
 
To evaluate the effect of AMG 301 
compared to placebo on the 
proportion of subjects with at least 
50% reduction from the baseline 
period in monthly migraine days 
 
Achievement of at least a 50% reduction 
from the baseline period in monthly 
migraine days in the last 4 weeks of the 
12-week double-blind treatment period 
 
To evaluate the effect of AMG 301 
compared to placebo on the change 
from the baseline period in monthly 
acute migraine‑specific medication 
treatment days 
 
Change from the baseline period in 
monthly acute migraine-specific medication 
days in the last 4 weeks of the 12-week 
double-blind treatment period. 
 
To evaluate the effect of AMG 301 
compared to placebo on the change 
from the baseline period in monthly 
physical impairment domain score 
as measured by the Migraine 
Physical Function Impact Diary 
(MPFID) 
 
Change from the baseline period in 
physical impairment domain scores as 
measured by the MPFID over the last 
4 weeks of the 12-week double-blind 
treatment period 


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 12 of 82 
 
 
CONFIDENTIAL 
 
The primary endpoints of the study will be tested for each of the AMG 301 210 mg and 
AMG 301 420 mg groups compared to placebo, respectively, at significance levels of 
0.05 and 0.05, respectively, to maintain a familywise type I error of 0.10. 
 
Null Hypothesis: In subjects with migraine, the AMG 301 treatment group is not 
different from placebo, in terms of the reduction of the monthly migraine days 
from baseline. 
 
Alternative Hypothesis: In subjects with migraine, the AMG 301 treatment group 
is different from placebo, in terms of the reduction of the monthly migraine days 
from baseline.  


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 13 of 82 
 
 
CONFIDENTIAL 
 
3. 
Study Overview 
3.1 
Study Design 
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, 3-arm 
parallel-group study of subjects with chronic migraine (CM) or episodic migraine (EM).  
Approximately 335 subjects will be randomized 4:3:3 to placebo, AMG 301 210 mg via 
SC injections QM, or AMG 301 420 mg via SC injections Q2W, respectively.  The 
randomization will have 2 stratification factors: baseline migraine frequency (CM versus 
EM) and region (North America versus Rest of World). 
Interactive Voice Response (IVR)/Interactive Web Response (IWR) system will be used 
to facilitate randomization and stratification and investigational product assignment.   
Stratification at Randomization: 
Baseline migraine frequency (CM versus EM; limit both CM and EM randomization to 
approximately 50% each of total sample size) and Region (North America versus Rest of 
World; neither region will enroll more than 60% of the total sample size). 
CM is defined as: 
 
≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days 
during the baseline period based on the electronic diary (eDiary) calculations  
EM is defined as:  
 
< 15 headache days of which at least 4 or more headache days meet criteria as 
migraine days during the baseline period based on the eDiary calculations 
After signing the informed consent form, subjects will enter the screening period.  The 
entire screening period includes a screening period (up to 3 weeks) followed by a 
4-week baseline period.  At the day 1 visit (the day 1 visit must occur 28 to 35 days after 
the week -4 baseline period visit date), eligible subjects will be randomized into the 
12-week DBTP) and will begin to receive double-blind investigational product.  At the 
week 10 visit, subjects will take the last dose of investigational product.  At the week 12 
visit, subjects will end the DBTP.  A safety follow-up period will be conducted 18 weeks 
after the last dose of investigational product (16 weeks after DBTP).  Subjects will use 
an eDiary every day throughout the baseline period, DBTP, and safety follow-up period 
to report information about the migraine and non-migraine headaches and acute 
medication use.  Subjects will have in-clinic study visits Q2W after day 1 through the 
week 12 visit and then Q4W. 
The overall study design is described by a study schema in Section 2.1 of the protocol. 


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 15 of 82 
 
 
CONFIDENTIAL 
 
4. 
Covariates and Subgroups 
4.1 
Planned Covariates 
Region (North America versus Rest of World) and baseline migraine frequency 
(CM versus EM) will be included in the repeated measures linear mixed models 
models as stratification factors. In addition, the baseline value corresponding to 
the endpoint being analyzed will also include.  
4.2 
Subgroups 
The primary and secondary endpoints may also be explored using subgroup 
analyses of region (North America, Rest of World), migraine frequency type (EM, 
CM), prior anti-CGRP medication use (Yes, No), prior migraine prophylactic 
treatment failure (1, ≥ 2), medication overuse (Yes, No), CAP score (0,  ≥ 1), age 
(<Median, ≥ Median), sex (Female, Male), race (White, Other), response status to 
AMG 334 (Yes, No), and other subgroup variables as deemed appropriate. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 16 of 82 
 
 
CONFIDENTIAL 
 
5. 
Definitions 
5.1 
Endpoints 
5.1.1 
Efficacy Endpoints 
The baseline period for efficacy analysis is defined as the period between week -4 visit 
(date on which the eDiary device is set up) and the day prior to study day 1 (study day 1 
is not included). 
eDiary Day 
A day in which a subject uses the eDiary and data are entered for that day. 
Migraine Day 
A migraine day is any calendar day from the eDiary in which the subject experiences a 
qualified migraine headache (onset, continuation or recurrence of the migraine 
headache).  A qualified migraine headache is defined as a migraine with or without aura, 
lasting for ≥ 4 hours, and meeting at least one of the following criteria: 
a) ≥ 2 of the following pain features:  
 
Unilateral 
 
Throbbing 
 
Moderate to severe 
 
Exacerbated with exercise/physical activity 
b) ≥ 1 of the following associated symptoms:  
 
Nausea and/or vomiting  
 
Photophobia and phonophobia 
If the subject took a migraine-specific medication (ie, triptan or ergotamine) during aura 
or to treat headache on a calendar day, then it will be counted as a migraine day 
regardless of the duration and pain features/associated symptoms. 
Monthly Migraine Days 
Number of migraine days during a 28-day period. Monthly migraine days at baseline are 
the number of migraine days in the baseline period.  Days without eDiary data in each 
monthly interval are handled by proration according to Section 8.3.  


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 17 of 82 
 
 
CONFIDENTIAL 
 
Headache Day 
A headache day is any calendar day from the eDiary in which the subject experiences a 
qualified headache (initial onset, continuation or recurrence of the headache).  A 
qualified headache is defined as: 
 
a qualified migraine headache (including an aura-only event that is 
treated with acute migraine-specific medication), or 
 
a qualified non-migraine headache, which is a headache that lasts 
≥ 4 hours and is not a qualified migraine headache, or 
 
A headache of any duration for which acute headache treatment is 
administered. 
Monthly Headache Days 
Number of headache days during a 28-day period. Monthly headache days at baseline 
are the number of headache days in baseline period.  Days without eDiary data in each 
monthly interval are handled by proration according to Section 8.3. 
Information Day 
A day which is either a headache day or an eDiary day. 
Migraine Attack 
A migraine attack is an episode of any qualified migraine headache or migraine specific 
medication intakes for aura only.  The following rules will be used to distinguish an attack 
of long duration from two attacks, or to distinguish between attacks and relapses: 
a) A migraine attack that is interrupted by sleep, or temporarily remits, and then 
recurs within 48 hours will be considered as one attack and not two. 
b) An attack treated successfully with medication but with relapse within 48 hours 
will be considered as one attack. 
A migraine attack lasting more than 48 hours will be counted as one attack. 
Monthly Migraine Attacks 
Number of migraine attacks during each 28-day period.  Monthly migraine attacks at 
baseline are the number of migraine attacks in baseline period.  Days without eDiary 
data are handled by proration according to Section 8.3. 
Response 
At least a 50% (or at least 75% or 100%) reduction from baseline in monthly 
migraine days over the last 4 weeks of the DBTP.  


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 18 of 82 
 
 
CONFIDENTIAL 
 
Monthly Acute Headache Medication Treatment Days 
Number of days on which acute headache medications are used as recorded in eDiary 
during each 28-day period.  Monthly acute headache medication treatment days at 
baseline are the number of acute headache medication treatment days in the baseline 
period.  Days without eDiary data are handled by proration according to Section 8.3. 
Monthly Acute Migraine-specific Medication Treatment Days 
Number of days on which migraine specific medications are used during each 28-day 
period.  Migraine-specific medications include two categories of medications: 
triptan-based migraine medications and ergotamine-based migraine medications. 
Monthly migraine-specific medication treatment days at baseline are the number of 
migraine-specific medication treatment days in the baseline period.  Days without eDiary 
data are handled by proration according to Section 8.3. 
Monthly Average Severity of Migraine Pain 
Severity of migraine pain is graded as 1=mild, 2=moderate or 3=severe and is rated as 
its worst or peak intensity per migraine headache.  The monthly average severity of 
migraine pain is defined as the sum of the severity of each observed qualified migraine 
headache during each 28-day period divided by the total number of observed qualified 
migraine headaches (as one record in eDiary with start and end time) in that interval.  If 
fewer than 14 days of eDiary data in each interval is recorded, then the monthly average 
severity of migraine pain will be set as missing.  Monthly average severity of migraine 
pain at baseline is the average severity of migraine pain in the baseline period.  
Clinical Outcomes Assessments (COA) and Electronic Diaries (eDiaries) 
The Clinical Outcomes Assessments (COAs) will be collected by subjects using a 
handheld eDiary at various frequencies. The eDiary will collect the following COAs daily 
at home: 
 
Date and time of start of headache (ie, migraine or non-migraine headache) 
 
Date and time of end of each headache 
 
Worst pain severity per headache 
 
Pain features (eg, 1-sided, throbbing, worsens with exercise/physical activity) 
 
Symptoms (eg, aura, nausea, vomiting, photophobia, phonophobia) 
 
Use of acute medications (medication name [from pre-entered list] date of 
dosing, number of times taken of each date, number of units taken) 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 19 of 82 
 
 
CONFIDENTIAL 
 
The subject’s eDiary will also be used for the completion of the following patient-reported 
outcomes (PROs) measures: 
 
HIT-6, monthly in clinic 
 
Modified MIDAS questionnaire; monthly in clinic 
 
MPFID, daily at home 
Headache Impact Test (HIT-6) 
The Headache Impact Test (HIT-6) is a short-form self-administered questionnaire 
based on the Internet-HIT question pool.  The HIT-6 was developed as a global measure 
of adverse headache impact to assess headache severity in the previous month and 
change in a patient’s clinical status over a short period of time.  Six questions cover:  
 
severe pain,  
 
limitation of daily activity (household, work, school and social), 
 
wanting to lie down when headache is experienced, 
 
feeling too tired to work or do daily activities because of headache, 
 
feeling fed up or irritated because of headache, 
 
headache limiting ability to concentrate or work on daily activities. 
Each of the 6 questions is responded to using 1 of 5 response categories: “never,” 
“rarely,” “sometimes,” “very often,” or “always.”  
For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the 
response provided.  These points are summed to produce a total HIT-6 score that 
ranges from 36 to 78.  The HIT-6 score is categorized into 4 grades, representing little or 
no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe 
impact (60-78) due to headache.  No recall period is specified for the first 3 items.  The 
recall period is the past 4 weeks for the last 3 items. Subjects will complete the HIT-6 
using the eDiary at the clinical assessment visit. Please refer to Appendix E for scoring 
algorithm. 
Modified Migraine Disability Assessment (MMIDAS) 
The modified Migraine Disability Assessment Questionnaire (MMIDAS) is a 5-item 
self-administered questionnaire that sums the number of productive days lost over the 
past month in two settings: the workplace and the home.  The MMIDAS also assesses 
disability in family, social, and leisure activities.  The MMIDAS score is the sum of 
missed days due to a headache from paid work, housework, and non-work 
(family, social, leisure) activities; and days at paid work or housework where productivity 
was reduced by at least half.  The original MIDAS was a 3-month recall assessment. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 20 of 82 
 
 
CONFIDENTIAL 
 
In order to categorize severity of subjects with the MMIDAS, the total score is 
multiplied by 3 and categorized into 4 severity grades: Grade I = 0 - 5 (defined as 
minimal or infrequent disability), Grade II = 6 - 10 (mild or infrequent disability), 
Grade III = 11 - 20 (moderate disability), and Grade IV = 21 and over (severe disability).  
The recall period is the past one month. 
Subjects will complete the modified MMIDAS monthly using the eDiary.  Please refer to 
Appendix E for scoring algorithm. 
Migraine Physical Function Impact Diary (MPFID) 
The MPFID is a self-administered 13-item instrument measuring physical functioning. It 
has 2 domains, Impact on Everyday Activities (7 items) and Physical Impairment 
(5 items), and 1 stand-alone global question that provides an assessment of the overall 
impact of migraine on subjects’ everyday activities. The recall period for each item is the 
past 24 hours.  
Subjects respond to items using a 5-point scale, with difficulty items ranging from 
“Without any difficulty” to “Unable to do” and frequency items ranging from “None of the 
time” to “All of the time”. These are assigned scores from 1 to 5, with 5 representing the 
greatest burden. For each domain, the scores will be calculated as the sum of the item 
responses and the sum will be rescaled to a 0 to 100 scale, with higher scores 
representing greater impact of migraine (ie, higher burden). There will be a score for 
each of the 2 domains and a third score for the stand-alone item.  
The recall period is the past 24 hours. 
Please refer to Appendix E for more information. 
Subjects will complete the MPFID every day using the eDiary.  
Monthly Days with Impairment as Measured by MPFID 
If ≥ 50% of the 13 daily items are completed, this is the number of days with a response 
of 3, 4, or 5 on any item of the MPFID between each monthly IP dose. Monthly days with 
impairment at baseline is the number of impairment days during the baseline period. 
Days with < 50% of the 13 daily items completed are handled by proration according to 
Section 8.3. 
Monthly Days with Physical Impairment as Measured by MPFID Physical 
Impairment (PI) Domain 
If ≥ 50% of the daily items within the PI domain are completed, this is the number of 
days with a response of 3, 4, or 5 on any of the 5 daily items on the PI domain between 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 21 of 82 
 
 
CONFIDENTIAL 
 
each monthly IP dose.  Monthly days with physical impairment at baseline is the number 
of impairment days during the baseline period. Days with < 50% of the 5 daily items in 
the PI domain completed are handled by proration according to Section 8.3. 
Monthly Day with Impact on Everyday Activities as Measured by MPFID Everyday 
Activities (EA) Domain 
If ≥ 50% of the daily items within the EA domain are completed, this is the number of 
days with a response of 3, 4, or 5 on any of the 7 daily items on the EA domain between 
each monthly IP dose. Monthly days with impact on everyday activities at baseline is the 
number of impairment days during the baseline period. Days with < 50% of the 7 daily 
items in the EA domain completed are handled by proration according to Section 8.3. 
Achievement of at least a 50% reduction from baseline in monthly migraine days 
over the last 4 weeks of the DBTP 
Calculated based on the following: if (monthly migraine days over the last 4 weeks of the 
DBTP - baseline monthly migraine days) * 100 / baseline monthly migraine days is less 
than or equal to - 50% 
Change from baseline in monthly acute migraine-specific medication treatment 
days over the last 4 weeks of the DBTP 
Calculated based on the following: (monthly acute migraine-specific medication 
treatment days over the last 4 weeks of the DBTP) – (baseline monthly acute 
migraine-specific medication treatment days)  
Change from baseline in monthly average physical impairment scores as 
measured by the MPFID over the last 4 weeks of the DBTP 
Calculated based on the following: (monthly average physical impairment scores as 
measured by the MPFID over the last 4 weeks of the DBTP) – (baseline monthly 
average physical impairment scores as measured by the MPFID) 
Change from baseline in monthly average impact on everyday activities scores as 
measured by the MPFID over the last 4 weeks of the DBTP 
Calculated based on the following: (monthly average impact on everyday activities 
scores as measured by the MPFID over the last 4 weeks of the DBTP) – (baseline 
monthly average impact on everyday activities scores as measured by the MPFID) 


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Achievement of at least a 5-point reduction from baseline in monthly average 
impact on everyday activities/physical impairment domain scores over the last 
4 weeks of the DBTP 
The achievement of at least a 5-point reduction from baseline in monthly average impact 
on everyday activities/physical impairment domain scores as measured by the MPFID is 
calculated based on the following: 
If (monthly average impact on everyday activities/physical impairment domain score over 
the last 4 weeks of the DBTP - baseline monthly average impact on everyday 
activities/physical impairment domain score) is less than or equal to -5 
Cranial Autonomic Parasympathetic Symptom (CAPS) Scale 
The CAPS Scale is a 5-item questionnaire that assesses whether migraine subjects 
experience each of the following 5 CAPS based on the ICHD, third edition beta 
(ICHD-IIIb), with headaches:  1) lacrimation, 2) conjunctival injection, 3) eyelid 
edema, 4) sensation of fullness in the ear and 5) nasal congestion and/or 
rhinorrhea. Each CAPS (eg, consider all headaches experienced over the past 
4 weeks) is graded as either 0 (absent), 1 (present but mild) or 2 (present and 
conspicuous). The CAPS total score ranges from 0 to 10 points. (Riesco et al, 
2016). 
The CAPS scale will be administered by clinical study center staff as described in 
Table 2-1 of the protocol. 
5.1.2 
Safety Endpoints 
Treatment-emergent Adverse Event (TEAE) 
An adverse Event (AE) recorded on the Events eCRF page that occurs on or after the 
date of the first dose of investigational product (IP), as determined by the flag indicating 
the event did not start before first dose of IP on the Events eCRF, and up to and 
including 126 days after the end of IP (ie. 18 weeks after the last dose of IP).  
Serious TEAE 
A serious treatment-emergent adverse event is an SAE considered to be 
treatment-emergent. 
Disease-Related Event (DRE) 
Disease-related Events (DREs) are events determined by the flag on the Event 
CRF. 


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Columbia-Suicide Severity Rating Scale (C-SSRS) 
The C-SSRS is a clinician rating of suicidal behavior and ideation.  Two versions 
depending on the type of visits will be used in this study: Screening and Since Last Visit. 
The C-SSRS consists of a maximum of 20 items, which defines 5 subtypes of suicidal 
ideation and behavior in addition to self-injurious behavior with no suicidal intent. The 
C-SSRS will be administered by the principal investigator or qualified designee to 
evaluate suicidal behavior and suicidal ideation. For the baseline assessment, for 
measurements with multiple individual items, all individual items from the same set of 
measurement will be used for analysis.  
For C-SSRS, the last complete assessment prior to first IP administration will be used as 
the baseline. If subject completes C-SSRS form on Day 1 then all individual items from 
Day 1 visit will be used as baseline.  If subject does not complete C-SSRS form on 
Day 1 then all individual items from Week -4 visit will be used as baseline. Please refer 
to Appendix E for more information. 
Beck Depression Inventory (BDI)-II 
The BDI-II is a 21-item questionnaire that assesses severity of depression. Each item is 
scored from 0 to 3. The total score is categorized into 4 severity grades: Minimal 
depression (0-13), mild depression (14-19), moderate depression (20-28) and severe 
depression (29-63). Please refer to Appendix E for more information. 
5.2 
Study Dates 
Informed Consent Date 
The date on which subject signs the informed consent form. 
eDiary Device Assignment Date 
The date on which an eDiary device is assigned to a subject for the first time after 
completion of initial screening at week -4 visit and which is the beginning of the baseline 
period. 
Enrollment Date 
The date on which the investigator decides that the subject has met all Part 1 and Part 2 
eligibility criteria. The subject is also randomized per IVRS on this date. 
Randomization Date  
Randomization date is the date on which a subject is assigned to one of the treatments 
through the Interactive Voice Response System (IVRS). The randomization date is the 
same as the enrollment date. 


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First IP Dose Date 
The first IP dose date is the date on which a subject is administered the first dose of IP 
following randomization, which may be the same day or after the randomization date. 
For subjects who are randomized but not dosed with double-blind IP after randomization, 
the first IP dose date is considered missing. 
Last IP Dose Date 
The last IP dose date for each subject is defined as the latest date IP is administered. 
End of IP Admin Date 
The end of IP admin date for each subject is defined as the date the decision was made 
to end IP as recorded on the End of IP eCRF page. 
Subject-level End of Study (EOS) Date 
The end of study (EOS) date for each subject is defined as the last date on which the 
subject participated in the study.  The date will be recorded on the End of Study eCRF 
page. 
Subject-level End of Double Blind (EODB) Treatment Phase Date 
The end of double blind (EODB) treatment phase date for each subject is defined 
as the last date on which the subject participated in the double-blind treatment 
phase. The date will be recorded on the End of Double Blind eCRF page. 
Study Completion Date (Study-level EOS Date) 
The study completion date is the date when the last subject is assessed or receives an 
intervention for evaluation in the study (ie, when the last subject completes the study, 
which includes the safety follow-up visit 18 weeks after the last dose of IP, or is 
discontinued from the study).  
5.3 
Study Points of Reference 
Baseline Period 
The 4-week baseline period starts when the subject has met all Part 1 eligibility 
criteria (refer to Section 6.1 of the protocol) and is entered in the baseline period 
(refer to Section 6.6 of the protocol) and ends when the subject is considered a 
screen failure (discontinuation before randomization and/or subject does not meet all 
baseline eligibility criteria, refer to Section 6.3) or randomized. 
The first day of the baseline period is the day that the subject records the first 
assessment in the eDiary and the last day of this period is the date the subject records 
the last assessment prior to the first dose of IP on Study Day 1.  


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The baseline assessment is defined as the last non-missing measurement for the 
endpoint of interest taken before the first dose of IP.  In cases where baseline 
measurements are taken on the same day as the first dose of IP, it will be assumed that 
these measurements are taken prior to IP being administered.  For subjects who are 
randomized but not dosed after the randomization, the baseline of the study is defined 
as the last non-missing measurement prior to or on the date of randomization.  Above 
definition applies to safety measurements and PROs collected at office visits (HIT-6, 
CAPS and MMIDAS). 
For measurements with multiple individual items such as C-SSRS and ECG, all 
individual items from the same set of measurement will be used for analysis.  If some 
items from the same set are missing, then the latest complete set of measurement prior 
to the first dose of IP will be used as baseline.  A similar rule holds for post-baseline 
measurements. 
Baseline assessment of data collected from eDiary will be summarized as monthly 
measurements using data collected during baseline period. 
Study Day 1 
Study Day 1 is defined as the first IP dose date. For subjects who are randomized but 
not dosed after randomization, the Study Day 1 is defined as the date of randomization. 
Study Day 
Study Day is defined as the number of days from Study Day 1. 
Before Study Day 1: 
Study Day = (date of interest – date of Study Day 1) 
On or after Study Day 1: 
Study Day = (date of interest – date of Study Day 1) + 1 
Therefore the day prior to Study Day 1 is -1. 
5.4 
Study Time Intervals 
Monthly Interval for Efficacy Endpoints 
Monthly efficacy measurements will be calculated based on the 2-week IP dosing 
schedule defined below using eDiary data collected from the beginning of the baseline 
phase (week -4 visit) up to the end of the safety follow-up phase (week 28 end of eDiary 
use).  Any eDiary data occurring after EOS date or after the end date of the last monthly 
interval defined below, whichever comes earlier, will not be included in the analysis. 


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Table 5-1.  Monthly Interval for Efficacy Endpoints Derived From Daily eDiary Data 
Study Phase 
Assessment 
Time Point 
Monthly Interval  
Start Date/Day 
End Date/Day 
Baseline Phase  
Baseline 
eDiary device 
assignment date  
(week -4 visit)  
The day of or prior to Study 
Day 1 
Double-blind 
Treatment Phase 
Week 4 
Study Day 1 
 
Week 4 dose date – 1 
 
Else MIN(Study Day 28, 
EOS) if Week 4 dose was 
not received 
Week 8 
 
Week 4 dose 
date 
 
Else Study Day 
29 if Week 4 dose 
was not received 
 
Week 8 dose date – 1  
 
Else MIN(Study Day 56, 
EOS) if Week 8 dose was 
not received 
Week 12 
 
Week 8 dose 
date 
 
Else Study Day 
57 if Week 8 dose 
was not received 
 
MIN(Study Day 84, EOS) 
Safety Follow-up 
Period 
Week 16 
 Study Day 85  
 
MIN(Study Day 112, EOS) 
Week 20 
 Study Day 113  
 
MIN(Study Day 140, EOS)  
Week 24 
 Study Day 141  
 
MIN(Study Day 168, EOS) 
Week 28 
 Study Day 169  
 
MIN(Study Day 196, EOS)  
Study Visit 
Since the actual visit for a subject may not exactly coincide with their targeted 
visit date, the actual visit date is mapped to the study visit as following. The study 
day window will be utilized to define study visit for lab, vital signs, physical 
measurements and PROs collected during office visits including HIT-6, and 
MMIDAS. Any data occurring after the EOS date will not be included in the 
analysis with the exception of lab shift analyses and antibody data. 


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Table 5-2.  Study Visit Windows for HIT-6, MMIDAS, C-SSRS, and CAPS Scale 
Study Phase 
Study Visit 
Target Day 
Study Day 
Double-blind 
Treatment Period 
Baseline 
Please refer to Section 5.3 Baseline 
Assessment of the Study 
Week 4 
29 
 
2 –  43 
Week 8 
57 
 
44 –  71 
Week 12 
85 
 
72 –  99 
Safety Follow-up 
Period 
Week 16 
113 
 
100 – 127 
Week 20 
141 
 
128 – 155 
Week 24 
169 
 
156 – 183 
Week 28 
197 
 
184 – 211 
Table 5-3.  Study Visit Windows for Lab (Except HbA1C and Urinalysis) 
Study Phase 
Study Visit 
Target Day 
Study Day 
Double-blind 
Treatment Period 
Baseline 
Please refer to Section 5.3 Baseline 
Assessment of the Study 
Week 4 
29 
 
2 – 36  
Week 6 
43 
 
37 – 64 
Week 12 
85 
 
65 – 99 
Safety Follow-up 
period 
Week 20 
141 
 
100 – 169 
Week 28 
197 
 
170 – 211  
Table 5-4.  Study Visit Windows for HbA1C 
Study Phase 
Study Visit 
Target Day 
Study Day 
Double-blind 
Treatment Period 
Baseline 
Please refer to Section 5.3 Baseline 
Assessment of the Study 
Week 6 
43 
 
2 – 64 
Week 12 
85 
 
65 – 99 
Safety Follow-up 
period 
Week 20 
141 
 
100 – 169 
Week 28 
197 
 
170 – 211  


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Table 5-5.  Study Visits for Vital Signs 
Study Phase 
Study Visit 
Target Day 
Study Day 
Double-blind 
Treatment Period 
Baseline 
Please refer to Section 5.3 Baseline 
Assessment of the Study 
Day 1 
1 
 1  
Week 2 
15 
 
2 – 22  
Week 4 
29 
 
23 – 36  
Week 6 
43 
 
37 – 50  
Week 8 
57 
 
51 – 64 
Week 10 
71 
 
65 – 78 
Week 12 
85 
 
79 – 99  
Safety Follow-up 
period 
Week 16 
113 
 
100 – 127 
Week 20 
141 
 
128 – 155  
Week 24 
169 
 
156 – 183  
Week 28 
197 
 
184 – 211 
Table 5-6.  Study Visits for Physical Examination 
Study Phase 
Study Visit 
Target Day 
Study Day 
Double-blind 
Treatment Period 
Baseline 
Please refer to Section 5.3 Baseline 
Assessment of the Study 
Week 12 
85 
 
1 – 99  
Safety Follow-up 
period 
Week 28 
197 
 
100 – 211 


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Table 5-7.  Study Visits for PK 
Study Phase 
Study Visit 
Target Day Study Day 
Double-blind 
Treatment Period 
Baseline 
Please refer to Section 5.3 Baseline 
Assessment of the Study 
Week 1 
8 
 
2 – 15  
Week 4 
29 
 
16 – 43  
Week 8 
57 
 
44 – 60  
Week 9 
64 
 
61 – 67 
Week 10 
71 
 
68 – 78 
Week 12 
85 
 
79 – 99  
Safety Follow-up 
period 
Week 16 
113 
 
100 – 141  
Week 24 
169 
 
142 – 183  
Week 28 
197 
 
184 – 211  
Table 5-8.  Study Visits for Antibody  
Study Phase 
Study 
Visit 
Target Day 
Study Day 
Double-blind 
Treatment Period 
Baseline 
Please refer to Section 5.3 Baseline 
Assessment of the Study 
Week 8 
57 
 
2–  71  
Week 12 
85 
 
72 – 99 
Safety Follow-up 
period 
Week 16 
113 
 
100 – 141 
Week 24 
169 
 
142 – 183  
Week 28 
197 
 
184 – 211  
Note: 
If more than one visit (including the unscheduled visits, ie, CPEVENT = ‘UNSCHED’) 
falls within the same defined window with non-missing measurements, the closest visit 
to the target day will be considered for analysis. If two assessment dates are 
equidistant from the target date, the latter visit will be considered for analysis. The 
baseline assessment is defined as the last non-missing measurement for the endpoint of 
interest taken before the first dose of IP.  In cases where baseline measurements are 
taken on the same day as the first dose of IP and the measurement time is not 
collected, it will be assumed that these measurements are taken prior to IP being 
administered 


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5.5 
Subject Disposition 
Enrolled 
Individuals are considered enrolled when they have met Part 1 and Part 2 eligibility 
criteria Enrolled individuals are referred as “subjects”. 
Randomized 
Individuals are considered randomized if they have been assigned a randomization 
number.  Randomized individuals are referred to as “subjects”. 
Completing the DBTP 
Subjects are defined as completing the DBTP if they complete the week 12 
assessment. It will be derived from the End of Double-blind Treatment Phase 
eCRF with “Completed” as the reason for ending study phase.   
Completing Study 
Subjects are defined as completing study if they complete the whole 28 weeks of study 
evaluation.  It will be derived from the End of Study eCRF page with “Completed” as the 
primary reason for ending study. 
Exposed to IP 
Subjects are defined as exposed if they receive at least one dose of IP. 
Completing the Double-Blind IP 
Subjects are defined as completing double-blind IP if they complete week 10 IP dose.  It 
will be derived from the End of Investigational Product Administration eCRF page 
with “Completed” as the reason for ending IP. 
On-study 
Subjects are considered on-study if they have been randomized and have not yet had 
their end of study visit. 
5.6 
Arithmetic Calculations 
Duration of Migraine 
The number of years from the diagnosis date (DXDT) of migraine (migraine with aura or 
migraine without aura, whichever is earlier) to the date informed consent is signed. 


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If month or day of the diagnosis date is missing, follow the formula below to calculate the 
duration: 
Observed portion 
Missing 
portion 
Formula to Calculate Duration 
Year, Month, Day 
 
(Informed Consent Day – DXDT)/365.25 
Year, Month  
Day  
[Year(Informed Consent Day)-Year(DXDT)]+ 
[Month(Informed Consent Day)-Month(DXDT)]/12 
if it equals 0, add 1 month or 1/12 years (this is to avoid 
a disease duration of 0) 
Year 
Month, Day 
[Year(Informed Consent Day)-Year(DXDT)]   
if it equals 0, add 1 month or 1/12 years (this is to avoid 
a disease duration of 0) 
Exposure 
For all calculations of exposure, dose date refers to receiving dose > 0, but can include 
partial dose. 
Age at Onset of Migraine 
Age at enrollment – [date at enrollment in years-DXDT of migraine in years (migraine 
with aura or migraine without aura]  
Duration of DB IP Exposure 
Duration = Minimum (Last DB Dose Date + 27, EOS Date) – First DB Dose Date + 1 
Change from Baseline in Monthly Efficacy Measurement 
The change from baseline in monthly efficacy measurement is the monthly efficacy 
measurement in the monthly interval prior to the given time point minus the baseline 
monthly efficacy measurement.  Please refer to the Monthly Interval for Efficacy 
Endpoints defined in Section 5.4.  For example, change from baseline in monthly 
migraine days for Week 12 will be calculated based on the following: 
(Monthly migraine days during the week 12 interval) – (monthly migraine days during 
the baseline phase)  
If the baseline or post-baseline value is missing, then the change from baseline is set to 
missing. 
The following efficacy endpoints will be calculated as above: 
 
Change from baseline in monthly migraine days 
 
Change from baseline in monthly acute migraine-specific medication 
treatment days 


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 
Change from baseline in monthly physical impairment domain score as 
measured by the MPFID  
 
Change from baseline in monthly impact on everyday activities scores 
as measured by the MPFID 
 
Change from baseline in monthly headache (migraine and non-migraine 
headache) days 
 
Change from baseline in monthly average severity of migraine pain 
 
Change from baseline in monthly acute headache medication treatment 
days 
 
Change from baseline in monthly mean overall impact on everyday 
activities as measured by the MPFID stand-alone item  
 
Change from baseline in monthly days with impact on everyday 
activities as measured by the MPFID domain 
 
Change from baseline in monthly days with physical impairment as 
measured by the MPFID domain 
 
Change from baseline in the Cranial Autonomic Parasympathetic 
Symptom (CAPS) scale total score 
 
Change from baseline in monthly migraine-related disability and 
productivity as measured by MMIDAS 
 
Change from baseline in daily activity impact of headache as measured 
by HIT-6 
 
Change from baseline in the first 4 weeks in monthly migraine days 
Change from Baseline in Mean Monthly Efficacy Measurement over Multiple 
Months 
 
The Change from Baseline in Mean Monthly Efficacy Measurement is 
the Arithmetic mean of monthly values for the months considered - 
baseline monthly value 
Percent Change from Baseline 
The change from baseline divided by baseline and multiplied by 100:  
(Post-baseline – Baseline) * 100 / Baseline  
If the baseline value is 0 and the post-baseline value is also 0, then the percent change 
from baseline is set to 0. If the baseline value is 0 and the post-baseline value is 
non-zero, then the percent change from baseline is set to be missing 
Percent change from baseline in (mean) monthly migraine days which is used to 
determine 50%, 75%, and 100% responder will be calculated as above. 
Subject Incidence 
The subject incidence for a given event in a given period is defined as the number of 
subjects with at least one reported occurrence of the event divided by the number of 


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subjects who entered that period.  For subjects with multiple occurrences of the same 
event, the event will only be counted once per subject. 
Medication Overuse at baseline 
Medication overuse at baseline will be considered if any of the following criteria 
are present: 
 
≥ 15 days of simple analgesic, 
 
≥ 10 days of triptans, 
 
≥ 10 days of ergotamines, 
 
≥ 10 days of combination therapy intake of any combination of 
ergotamines, triptans, opiates, combination-analgesic medication (includes 
the case of more than 1 medication category within one visit). 
Medication Overuse during the DBTP 
Medication overuse will be considered present if any of the following criteria are met 
during a single month of the DBTP: ≥ 15 days of simple analgesics; ≥ 10 days of 
triptans; ≥ 10 days of ergotamines; ≥ 10 days of combination therapy intake of any 
combination of ergotamines, triptans, opiates, combination-analgesic medications. 
5.7 
Disease Characteristics 
Migraine-Specific Medications 
Migraine-specific medications include two categories of medications: triptan-based and 
ergotamine-based migraine medications collected from the subject’s eDiary.  
Treatment Failure of Migraine Prophylactic Medications 
Treatment failure of prior migraine prophylactic medications is determined by 
“Reason for stopping” as “Intolerance” or “Lack of efficacy” in the Migraine 
Prophylactic Medication eCRF page. 
Response Status to AMG 334 
At least a 50% reduction from baseline in monthly migraine days at month 3 for 
subjects who received consecutive 3 doses of AMG334 since the first dose of 
AMG334.  


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6. 
Analysis Sets 
6.1 
Full Analysis Set 
The Full Analysis Set (FAS) consists of all subjects who were randomized in the study.  
The FAS will be used to tabulate subject disposition, demographic data, baseline 
disease characteristics, and important protocol deviations for all randomized subjects. 
6.2 
Primary Analysis Set 
The Primary Analysis Set (PAS) (ie, Efficacy Analysis Set) will be used to carry out the 
primary analyses of the efficacy endpoints. It consists of all subjects who were 
randomized, received at least 1 dose of investigational product, and have at least 1 
postbaseline monthly eDiary measurement.  Subjects will be analyzed according to their 
randomized treatment group, regardless of treatment received.  The PAS will be used to 
analyze all efficacy and PRO endpoints. 
6.3 
Safety Analysis Set 
The Safety Analysis Set (SAS) consists of all enrolled subjects who received at least 
1 dose of investigational product.  Subjects will be analyzed according to the randomized 
treatment unless a subject has received the incorrect dose during the entire DBTP 
period.  Where a subject has received the incorrect dose during the entire DBTP, the 
subject will be analyzed according to treatment received. Analyses for safety endpoints 
and summary of investigational product administration will use this analysis set. 
6.4 
Pharmacokinetic/Pharmacodynamic Analyses Set(s) 
All subjects who received AMG 301 and had at least one PK sample collected will be 
included in the Pharmacokinetic Analysis Set. These subjects will be evaluated for 
pharmacokinetics unless significant protocol deviations affect the data analysis or if key 
dosing, dosing interruption or sampling information is missing.  


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7. 
Planned Analyses 
7.1 
Interim Analysis and Early Stopping Guidelines 
After about 50% of the subjects have been enrolled in the DBTP and completed the 
week 12 visit, multiple independent, unblinded interim analyses will be performed for 
administrative purposes for future study planning and development based on the interim 
effect size results for the primary endpoint. The results of these interim analyses will not 
affect the execution of this study. The maximum number of interim analyses will be no 
more than 5.  
These administrative interim analyses will be conducted by an independent group that is 
internal to Amgen (eg, Clinical Therapeutic Area Head and 2 statisticians) and separate 
from the study team; the study team will remain blinded to the specific results.  
Subject-level treatment group assignment will only be available to Amgen personnel who 
comprise the external team until the study has been unblinded for the primary analysis.  
The primary endpoint (ie, change from baseline period in monthly migraine days) and 
the following secondary endpoints will be included: achievement of at least 50% 
reduction in monthly migraine days, and change from baseline period in monthly acute 
migraine-specific medication days.  No safety data will be included.   
An internal unblinded team will perform the interim analyses and provide the interim 
report. Members will review all available safety and efficacy data periodically after at 
least 50% of the subjects have been enrolled and have completed the week 12 visit. The 
internal team will have access to subjects’ individual treatment assignments. To 
minimize the potential introduction of bias to the conduct of the study, members of the 
interim analysis group will not have any direct contact with study center personnel or 
subjects. 
An independent Data Review Team (DRT) will review and make recommendations 
regarding the safety of the study participants throughout the DBTP and until treatment 
assignment is unblinded to the study team. The DRT will be composed of Amgen staff 
that are external to the study team and will include a clinician, a safety physician, and a 
biostatistician. Summaries of data at the treatment group level will be prepared and 
presented by an independent biostatistician at the DRT meeting. A study DRT charter 
will be developed to guide membership, procedures, and meeting timing. 


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7.2 
Primary Analysis 
The objective of the primary analysis will be to test the primary efficacy endpoint once 
the primary completion milestone is achieved after the last subject reaches the last visit 
in the DBTP, and all data are collected for the primary endpoint.  At this time, the study 
will be unblinded and all efficacy and safety analyses will be conducted and reported by 
treatment group for both CM and EM. Safety data collected during safety follow-up 
before the data cutoff date for the primary analysis will also be summarized. 
The following hypothesis for the primary endpoint will be tested for each AMG 301 
treatment group (420 mg SC injections Q2W, 210 mg SC injections Q4W) compared to 
placebo using the generalized linear mixed effects model: 
 
Clinical Hypothesis: In subjects with CM and EM, AMG 301 reduces the monthly 
migraine days from the baseline period, compared to placebo 
To maintain a family-wise type I error at 0.10 for the testing of the primary endpoint, the 
pair-wise comparison will be tested for both (1) AMG 301 420 mg SC injections Q2W 
versus placebo and (2) AMG 301 210 mg SC injections Q4W versus placebo, each at an 
alpha level of 0.05.   
7.3 
Final Analysis 
The final analysis will be completed after study completion is reached, after the last 
subject reaches the last visit during the safety follow-up period, and all data are collected 
for the study. The safety analyses will be summarized for both the DBTP and safety 
follow-up phase combined. In addition, any changes made in the database for data 
from the double-blind treatment period and following the completion of the primary 
analyses will be noted. Any changes to data from the double-blind phase will be listed 
and an assessment will be made to determine if any of the primary analyses should be 
rerun.  Where this is the case, any changes in results and/or study conclusions will be 
documented in the clinical study report (CSR). 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 37 of 82 
 
 
CONFIDENTIAL 
 
8. 
Data Screening and Acceptance 
8.1 
General Principles 
The objective of the data screening is to assess the quantity, quality, and statistical 
characteristics of the data relative to the requirements of the planned analyses. 
8.2 
Data Handling and Electronic Transfer of Data 
The Amgen Global Study Operations-Data Management (GSO-DM) department will 
provide all data to be used in the planned analyses.  This study will use the RAVE 
database. 
8.3 
Handling of Missing and Incomplete Data 
Subjects may miss specific data points for a variety of causes.  In general, data could be 
missing due to a subject’s early withdrawal from study, a missed visit, or inability to 
evaluate an endpoint at a particular point in time.  For this study, most of the efficacy 
endpoint will be collected via eDiary and subjects could miss entering several days of 
data in each monthly interval.  The general procedures outlined below describe what will 
be done when a data point is missing.   
In general, the PAS will be used without any subject-level imputation for missing data for 
the primary and secondary endpoints, except for proration performed for the eDiary 
measurements, as described below.  The sensitivity analyses for both primary and 
secondary analyses will use non-responder imputation for categorical endpoints and 
multiple imputation with the assumption of missing not at random (MNAR) (with 
control- based pattern imputation) for the continuous endpoints.   
Missing eDiary data in the calculation of monthly measurements about subjects’ 
migraine and non-migraine headaches and missing daily scores of impairment day 
based on MPFID will be handled based on the degree of completion during the month. 
For the eDiary, if at least 14 out of 28 monthly days are not missing, then the monthly 
frequency measurements (eg, migraine days, headache days, migraine attacks) will be 
prorated based on the number of days with available information using the following 
formula: 
Number of observed migraine days *28/Number of information days in interval, 
where an information day is a diary day or headache day. 
For each MPFID daily diary domain, if greater than 50% of the items within a domain are 
not missing, the mean of the item scores that are present for that day will be used to 
impute a score for the missing item(s).  Otherwise, no domain score will be calculated; 
the domain score will be considered missing. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 38 of 82 
 
 
CONFIDENTIAL 
 
Table 8-1.  Handling of Missing and Incomplete eDiary Data 
Monthly Endpoint 
Condition 
Proration Method (does not 
need to be rounded) 
Monthly frequency 
measurements (including 
migraine days, headache 
days, migraine attacks, 
acute headache medication 
treatment days, acute 
migraine-specific medication 
treatment days) 
If diary days in entire baseline 
or interval post baseline >=14 
(including retrospective 
eDiary days), then do 
proration; 
Else monthly measurement is 
set to missing 
[A diary day is a day with all 
headache related questions 
completed retrospectively or 
not] 
Number of observed migraine 
days * 28/ Number of 
information days in interval 
 
[information day is a diary day 
or headache day] 
Monthly average of severity 
of migraine pain (1-3 scale) 
If diary days in entire baseline 
or interval post baseline >=14 
(including retrospective 
eDiary days), then calculate 
the average; 
Else missing 
Arithmetic mean of the 
observed pain scores of 
qualified migraine headaches 
over the monthly interval 
Monthly average of MPFID 
domain scores 
If days with observed daily 
domain score in interval >=14 
then calculate the average; 
Else missing 
Arithmetic mean of the 
observed daily domain score 
over the monthly interval 
Monthly impairment day for 
Everyday Activity and 
PhysicaI Impairment 
domains and overall 
If days with observed daily 
domain score in interval >=14 
then do the proration; 
Else missing 
Number of observed 
impairment days * 28/ Number 
of days with domain score in 
monthly interval 
Completely missing COAs and subject-completed assessments (eg, HIT-6, MIDAS) 
scheduled to be collected at office visit at certain assessment will not be imputed. 
Missing safety endpoints and antibody data will not be imputed, except for adverse event 
dates as described in Section 8.3.  
8.3.1 
Missing and Incomplete Dates 
Missing or incomplete dates will be listed unless imputed as follows: 
Incomplete start date of an adverse event or concomitant medication taken will be 
handled by following rule:  


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 39 of 82 
 
 
CONFIDENTIAL 
 
 
Missing 
Imputation 
Exception 
Start date  
(Adverse event, 
concomitant 
medication) 
Day 
01 
Default to Study Day 1 if an 
adverse event starts the 
same year and month as 
Study Day 1 and the flag 
indicates that the adverse 
event started on or after the 
first dose on the Adverse 
Events eCRF 
Day/Month 
01 JAN 
Default to Study Day 1 if an 
event started the same year 
as Study Day 1 and the flag 
indicates that the adverse 
event started on or after the 
first dose on the Adverse 
Events eCRF 
Day/Month/Year 
No imputation 
 
8.3.2 
Missing Baseline Evaluation 
Baseline values are defined in Section 5.3 “Baseline Assessment”.  Missing baseline 
evaluations will not be imputed. 
All subjects included in the primary analysis set will have baseline monthly rate or 
monthly baseline average of migraine and non-migraine headaches related 
measurements after applying proration rule defined in Section 8.3 since only subjects 
with ≥ 80% compliance of eDiary use during baseline will be eligible for randomization. 
8.3.3 
Missing Post-baseline Evaluation in the DBTP 
Primary analysis of continuous efficacy endpoints during the 12-week randomized DBTP 
will be conducted using the generalized linear mixed model on observed data without 
subject-level imputation. 
In sensitivity analyses of primary and secondary efficacy endpoints during the 12-week 
DBTP, missing continuous monthly efficacy endpoints will be handled using multiple 
imputation (MI) with the assumption of missing not at random (MNAR) (with 
control-based pattern imputation).  The continuous monthly efficacy endpoints will be 
computed as the mean over the last four weeks of the DBTP based on the observed and 
imputed values. 
In the non-responder imputation (NRI) method, post-baseline missing dichotomous 
efficacy endpoints (responder [Yes/No] based on ≥50%, ≥75% and 100% reduction 
from baseline in monthly migraine days) during the DBTP will be imputed as 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 40 of 82 
 
 
CONFIDENTIAL 
 
non-responder at each corresponding time point.  The dichotomous endpoints derived 
based on the mean change from baseline over the last 4 weeks of the DBTP will be 
imputed as non-responder if the mean change from baseline over the last 4 weeks of the 
DBTP is missing.  
If the proportion of missing data for the primary endpoint is high (eg, > 20%), further 
analyses will be performed to  
 
examine the frequency and reason of missing data 
 
determine if there are any patterns in the missing data 
 
distinguish true missing values from other unknown values (eg, due to measurement 
or sample processing error) 
8.3.4 
Missing Safety-Follow up Period   
Missing data in the Safety Follow-up Period will be handled in the same way as missing 
data in the DBTP. 
8.4 
Detection of Bias 
This study has been designed to minimize potential bias by allocating treatment groups 
randomly, assessing endpoints and handling withdrawals without knowledge of the 
treatment.  Other factors that may bias the results of the study include:  
 
important protocol deviations likely to impact the analysis and interpretation of the 
efficacy endpoints  
 
inadvertent breaking of the blind before formal unblinding  
 
investigational product dosing non-compliance  
 
the timing of and reasons for early withdrawal from treatment and from study  
The incidence of these factors may be assessed. Important protocol deviations will be 
listed and/or tabulated in the CSR. If necessary, the incidence of other factors will be 
tabulated. 
Any breaking of the blind for individual subjects prior to formal unblinding of the study will 
be documented in the CSR. 
The timing of and reasons for early withdrawal from treatment and from study will be 
tabulated and/or listed. 
8.5 
Outliers 
Histograms will be examined to identify outliers in any of the continuous variables used 
in the analyses.  Unexpected and/or unexplained values in categorical data will be 
identified by utilizing frequency tables. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 41 of 82 
 
 
CONFIDENTIAL 
 
Outliers due to data entry errors will be corrected by the study team before final 
database lock.  The validity of any questionable values or outliers will be confirmed. 
Outliers or any questionable values with confirmed validity will be included in the 
analyses.  However, ad-hoc sensitivity analyses may be conducted to evaluate the 
influence of extreme values in the data. 
8.6 
Distributional Characteristics 
Continuous endpoints of change from baseline value will be analyzed under normality 
assumption. If they deviate appreciably from normality, appropriate transformations or 
the non-parametric alternatives, may additionally be considered. 
8.7 
Validation of Statistical Analyses 
Programs will be developed and maintained, and output will be verified in accordance 
with current risk-based quality control procedures.   
Tables, figures, and listings will be produced with validated standard macro programs 
where standard macros can produce the specified outputs.   
The production environment for statistical analyses consists of Amgen-supported 
versions of statistical analysis software; for example, the SAS System version 7.1 or 
later. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 42 of 82 
 
 
CONFIDENTIAL 
 
9. 
Statistical Methods of Analysis 
9.1 
General Considerations 
The primary objective of this study is to evaluate the effect of AMG 301 compared to 
placebo on the change from the baseline period in monthly migraine days, in subjects 
with CM or EM. 
The primary analysis will be performed when the last randomized subject completes the 
week 12 assessment or is discontinued from the study and all data are collected for the 
primary endpoint.  The final analysis for the study including DBTP and safety follow-up 
phase will be performed at the end of the study. 
Subjects will be analyzed based on their randomized treatment group assignment. 
Summary statistics by each treatment group will be tabulated at each visit.  For 
continuous endpoints, the descriptive statistics include: number of observations, means, 
medians, standard deviations, standard errors, first and third quartiles, minimums and 
maximums, and 2-sided 95% confidence intervals of the means (confidence intervals will 
be provided for efficacy endpoints only).  For categorical endpoints, the summaries will 
contain the number and percentage of subjects in each category. 
Change from baseline for efficacy endpoints during the DBTP will be summarized using 
the study baseline. 
Primary analyses for efficacy endpoints are based on a linear mixed effects model 
including treatment group, baseline value, stratification factors, scheduled visit, 
and the interaction of treatment group with scheduled visit in the model.  
Unadjusted p-values (not adjusted for multiple comparisons) will be provided for the 
comparisons between each AMG 301 treatment group vs. the placebo group for efficacy 
endpoints.  For continuous efficacy endpoints, the adjusted mean change from baseline 
for each treatment group, and the adjusted treatment difference compared to placebo, 
associated 95% confidence intervals, and p-values for pairwise comparisons will be 
reported.  For dichotomous efficacy endpoints, adjusted odds ratios compared to 
placebo, associated 95% confidence intervals, and p-values will be reported.  Values for 
stratification factors as used during randomization will be utilized in the efficacy analysis 
instead of the subject’s actual value.  However, the actual value will be used in analyses 
of baseline characteristics or in the subgroup analyses of the efficacy endpoints. 
To maintain a family-wise type I error rate at 0.10 for the primary endpoint, the AMG 301 
210 mg treatment group and the AMG 301 420 mg treatment group will each be tested 
separately vs placebo at a significance level of 0.05. 


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 44 of 82 
 
 
CONFIDENTIAL 
 
9.4 
Demographic and Baseline Characteristics 
Subject demographic and baseline characteristics will be summarized using descriptive 
statistics by randomized treatment group and overall study population using FAS.  If 
multiple races have been reported for a subject, the subject will be categorized as 
multiple races. 
The following demographic and baseline characteristics will be summarized:  
 
Sex (categorical) 
 
Ethnicity (categorical) 
 
Race (categorical) 
 
Age (continuous, categorical) 
 
Region (categorical, North America vs. Rest of World) 
 
Height (continuous, cm) 
 
Weight (continuous, kg) 
 
Body Mass Index (continuous, BMI, kg/m2) 
 
Baseline migraine type (categorical, CM vs. EM) 
 
Prior participation in CGRP trial (categorical) 
 
≥ 50% reduction in MMD after receiving erenumab for 3 months (Categorical) 
 
Targeted neurological disease diagnosis at baseline (categorical: migraine 
with aura, migraine without aura, depression, anxiety, other) 
 
Acute headache medication use during baseline phase:  
a) Migraine-specific 
b) Non migraine-specific 
 
Monthly acute migraine-specific medication days in subjects who received 
acute migraine-specific treatment (continuous) 
 
Monthly acute migraine-specific medication days (continuous) 
 
Number of prior migraine prophylactic treatment category failed (categorical) 
 
Beck Depression Inventory (BDI)-II total score severity grade (categorical) 
 
Age at onset of migraine (continuous) 
 
Disease duration of migraine with or without aura (continuous) 
 
Monthly migraine days (continuous) 
 
Monthly headache days (continuous) 
 
Modified Migraine-specific and Migraine Disability Assessment (MMIDAS) 
(continuous, categorical) 


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 46 of 82 
 
 
CONFIDENTIAL 
 
The primary analysis of efficacy endpoints will utilize the PAS.  Subjects will be analyzed 
according to their randomized treatment group regardless of the actual treatment 
received during the study.   
For primary analysis at week 12, the continuous change from baseline efficacy 
endpoints calculated by the method as specified in Section 5.6 will be analyzed using 
generalized linear mixed effect models including treatment group, stratification factors, 
scheduled visit, the interaction between treatment group and scheduled visit and the 
baseline value on observed data.  The dichotomous efficacy endpoints will be analyzed 
using the stratified Cochran-Mantel-Haenszel (CMH) test after the missing data are 
imputed as non-response. Detailed primary analysis methods, sensitivity analyses, and 
covariates included in the models are summarized in the table below. 
Table 9-1.  Summary of Efficacy Endpoints and Analysis Methods 
Endpoint 
Primary Summary and 
Analysis Method 
Sensitivity Analysis 
Primary Endpoint 
Change in monthly 
migraine days from 
baseline to the last 4 
weeks of the 12-week 
DBTP 
 
(Note: Results from time 
points other than week 12 
during the DBTP will also 
be generated in the same 
generalized linear mixed 
effect model.) 
Analysis Method I: 
1. Summary statistics by visit 
using observed data  
2. Least squares means from a 
generalized linear mixed 
effect model including 
treatment group, baseline 
values, stratification 
variables, scheduled visit, 
and interaction of treatment 
and scheduled visit using 
observed data 
1. Summary statistics by 
visit and analyze using 
an ANCOVA model with 
multiple imputation 
assuming 
MNAR(control-based 
pattern imputation) 
2. Summary statistics by 
visit and analyze using 
an ANCOVA model with 
observed data 
3. Subgroup analyses: 
Same as primary 
summary and analysis 
method. 
Page 1 of 3 
Footnotes defined on last page of the table 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 47 of 82 
 
 
CONFIDENTIAL 
 
Table 9-1.  Summary of Efficacy Endpoints and Analysis Methods 
Endpoint 
Primary Summary and 
Analysis Method 
Sensitivity Analysis 
Secondary Endpoints 
At least a 50% 
reduction from baseline 
in monthly 
migraine days in the 
last 4 weeks of the 
12-week DBTP 
(Note: Results from 
time points during 
DBTP will also be 
generated in the same 
model.) 
1. Summary statistics by 
visit using observed data  
2. Stratified 
Cochran-Mantel-Haensz
el (CMH) Test 
1. Summary statistics by visit and 
analyze using a logistic 
regression model, and using 
responder rate calculated using 
monthly migraine days  
2. A stratified 
Cochran-Mantel-Haenszel 
(CMH) test will be used after the 
missing data are imputed as 
non-response 
3. A generalized linear mixed 
effects model will be used on 
observed data 
4. Subgroup analyses: Same as 
primary summary and 
analysis method. 
Change from baseline 
in monthly acute 
migraine-specific 
medication treatment 
days in the last 4 weeks 
of the DBTP 
 
(Note: Results from 
individual time point 
during the DBTP will 
also be generated in 
the same generalized 
linear mixed effect 
model.) 
Analysis Method I (see 
above) 
Analysis Method II: 
1. Summary statistics by visit and 
analyze using an ANCOVA 
model with multiple imputation, 
assuming MNAR 
Change from baseline 
in monthly physical 
impairment scores as 
measured by MPFID at 
assessment time points 
 
(Note: Results from 
individual time point 
during the DBTP will 
also be generated in 
the same generalized 
linear mixed effect 
model.) 
Analysis Method I 
N/A 
Page 2 of 3 
Footnotes defined on last page of the table 


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 49 of 82 
 
 
CONFIDENTIAL 
 
9.5.1 
Analyses of Primary Efficacy Endpoint(s) 
For the primary analyses, the continuous primary endpoints will be tested using a 
generalized linear mixed model based on observed monthly data from 12-week DBTP 
with appropriate contrasts provided in Appendix B for pairwise treatment comparisons 
and overall linear trend. 
The model will include treatment group, baseline value, stratification factors which 
include region (North America vs Rest of World) and baseline migraine frequency type 
(CM vs. EM), scheduled visit, the interaction of treatment group with scheduled visit 
using the PAS without any imputation for missing data.  If applicable, the first-order 
autoregressive covariance structure is assumed.  Least squares means (LSMs) for each 
treatment group, standard errors, associated 95% confidence intervals, difference of 
LSMs compared to placebo group, associated 95% confidence intervals and unadjusted 
two-sided p-values will be tabulated by visit and treatment, as well as for the mean 
monthly values over the last month in the DBTP. 
The primary endpoint, change in monthly migraine days from baseline to the last 
4 weeks of the 12-week double-blind treatment phase, will be tested for each AMG 301 
treatment group (the AMG 301 420 mg SC injections Q2W and AMG 301 210 mg SC 
injections Q4W) compared to the placebo group using appropriate contrasts for pairwise 
comparisons. Each AMG 301 dose will be compared to placebo at an alpha of 0.05 to 
maintain the family-wise type I error at 0.10. The mean change from the baseline period 
for each treatment group, and the treatment difference, 95% confidence intervals, and 
p-values will be reported. 
Sensitivity analyses for the primary endpoint include subgroup analyses and an analysis 
of covariance model using data through week 12 data, in which missing values for 
continuous variables will be imputed by multiple imputation with the assumption of 
MNAR up to week 12. For dichotomous endpoints, missing values will be imputed by the 
NRI method. Sensitivity analysis described below will be performed for the primary 
endpoint: 
Summary statistics and ANCOVA model for continuous endpoint. Factors of treatment, 
baseline covariate and stratification variables will be included in the model. MI with 
assumption of MNAR (control-based pattern imputation) for continuous endpoints. 
1. Primary endpoint will be summarized by the subgroup of  
 
Region (North America, Rest of World) 
 
Migraine type (EM, CM) 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 50 of 82 
 
 
CONFIDENTIAL 
 
 
Prior use of anti-CGRP medication (yes, no) 
 
Prior migraine prophylactic treatment failures (1, ≥ 2) 
 
Medication overuse (yes, no) 
 
CAPS score (0, ≥ 1) 
 
Age (< median, ≥ median) 
 
Sex (female, male) 
 
Race (White, Other) 
 
Response status to AMG 334 (yes, no) 
The purpose of the subgroup analyses is to explore if the treatment effect varies across 
subgroups of interest.  Subgroup analyses are performed for primary efficacy endpoint 
using the same method as primary analysis method but performed within each 
interested subgroup.  The treatment difference (or odds ratio) with associated 95% 
confidence intervals and p-values will be reported within each subgroup. 
Note: if the subgroup is one of the stratification factors, the stratification factor will not be 
included in the model, but the other randomized stratum will be included (ie, if the 
subgroup is prophylactic migraine medication, then randomized region would be 
included in the model instead of randomized strata which combined both stratification 
factors). These subgroups will be re-examined for appropriateness and may be 
re-categorized (due to small sample size, for example, if there are < 10% of 
subjects within a subgroup) before unblinding.  The analyses of these subgroups 
will be exploratory in nature.   
The heterogeneity of the treatment effect across the subgroups will be evaluated for the 
primary endpoints by examining the treatment by subgroup interaction and a p-value will 
be presented.  For continuous endpoints, the primary analysis model with the addition of 
treatment group by subgroup interaction will be used.   
Primary summary and analysis method with treatment and stratification interaction for 
continuous endpoints: the interaction of treatment group by stratification variable will be 
tested with significant level of 0.15.  If the interaction term is significant, the interaction 
term will be included in the model as sensitivity analysis for the primary analysis method.  
Time from last dose of study drug to loss of response will be evaluated during the 
Safety Follow-up period. For responders, loss of response is defined as the first 
time the subject returns to < 50% reduction from the baseline period in monthly 
migraine days. For non-responders, loss of response will be evaluated by 


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CCI


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 52 of 82 
 
 
CONFIDENTIAL 
 
9.5.4 
Analyses of Clinical Outcome Assessments (COAs) and Patient 
Reported Outcomes (PROs) 
The COAs and PROs include MPFID, HIT-6, MMIDAS and CAPS. Change from 
baseline in total score (or subscale if applicable) of each COA and PRO (except 
endpoints described in the Section 9.5.1 above) will be reported during the DBTP. 
For HIT-6, in addition to the analysis of continuous change from baseline value, 
proportions of subject with a ≥ 5-point reduction from baseline and proportions of subject 
with HIT-6 ≥ 60 (severe impact) will be analyzed similarly as the primary analysis 
method for dichotomous efficacy endpoints described in Section 9.5.2 above. No 
sensitivity analysis will be conducted for COA and PROs except for MPFID. The PAS will 
be used to analyze COA and PRO endpoints. 
Table 9-2.  Summary of COA and PRO Endpoints and Analysis Methods 
Endpoint 
Primary Summary and Analysis Method 
Change from baseline in the daily 
activity impact of a headache as 
measured by the HIT-6 total score 
1. Summary statistics by visit using observed data 
2. Least squares mean at each time point calculated 
based on a linear mixed effects model including 
treatment group, baseline value, stratification factors, 
scheduled visit, and the interaction of treatment group 
with scheduled visit, without any subject-level 
imputation for missing data. 
Change from baseline in CAPS  
Same as above 
Change from baseline in 
migraine-related disability and 
productivity as measured by the 
modified MIDAS (Note: MIDAS scores 
are collected every month. The first 
post-baseline measurement of the 
modified MIDAS scores are at 
week 4) 
Same as above; using ANCOVA model instead of 
generalized linear mixed effect model. 
Change from baseline in monthly 
mean overall impact on everyday 
activities score as measured by 
MPFID stand-alone item 
Same as above; using ANCOVA model instead of 
generalized linear mixed effects model. 
Change from baseline in monthly 
days with physical impairment as 
measured by MPFID 
Same as above; using ANCOVA model instead of 
generalized linear mixed effects model. 
HIT-6 severity grade shift from 
baseline 
Summary statistics for DBTP only. Shift table will also 
be provided to compare baseline values vs the most 
extreme post-baseline values through the DBTP. 
MMIDAS severity grade shift from 
baseline 
Summary statistics for DBTP only. Shift table will also 
be provided to compare baseline values vs the most 
extreme post-baseline values through the DBTP. 
9.5.5 
Pharmacokinetic Endpoints 
AMG 301 exposure parameters of mean concentration over the DBTP will be estimated.  


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 53 of 82 
 
 
CONFIDENTIAL 
 
9.6 
Safety Analyses 
9.6.1 
Analyses of Primary Safety Endpoint(s) 
For safety endpoints, all randomized subjects who received at least one dose of IP (ie, 
SAS) will be analyzed based on the randomized treatment unless a subject has received 
the incorrect dose during the entire DBTP. 
No statistical testing comparing treatment groups will be performed in the safety 
analyses. 
Table 9-3.  Safety Endpoint Summary Table 
Endpoint 
Primary Summary and Analysis Method (Specify Analysis Set if FAS is 
Not Used) 
Secondary 
For safety endpoints, data for all enrolled subjects who received at least 
1 dose of investigational product (ie, SAS) will be analyzed based on the 
randomized treatment unless a subject has received the incorrect dose 
the entire period of interest (period or study). 
The Medical Dictionary for Regulatory Activities (MedDRA) version 21.1 
or later will be used to code all adverse events to a system organ class 
and a preferred term. All adverse events will be graded using the CTCAE 
Version 4 as described in Appendix 4 of the protocol. All adverse event 
tables will be summarized by treatment group. 
Subject incidence of adverse events will be summarized for all 
treatment-emergent adverse events, serious adverse events, adverse 
events leading to withdrawal of investigational product, and fatal adverse 
events. Adverse events will be tabulated by system organ class and 
preferred term in alphabetical order.  
In addition, subject incidence of all treatment-emergent adverse events 
and serious adverse events will be tabulated by system organ class, 
preferred term and CTCAE grade in alphabetical order. Subject 
incidence of all treatment-emergent adverse events and serious adverse 
events will also be tabulated by preferred term in descending order of 
frequency. 
No statistical testing comparing treatment groups will be performed for 
the safety analyses. Descriptive statistics will be provided for all safety 
endpoints. 
 
9.6.2 
Adverse Events and Disease-related Events 
Subject incidence of all treatment-emergent adverse events will be tabulated by system 
organ class and preferred term.  Tables of fatal adverse events, serious adverse events, 
adverse events leading to withdrawal from investigational product or other 
protocol-required therapies, and significant treatment emergent adverse events will also 
be provided. Subject incidence of disease-related events and fatal disease-related 
events, if applicable, will be tabulated by system organ class and preferred term. 
Disease-related events will be combined with other adverse events for the tabulations. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 54 of 82 
 
 
CONFIDENTIAL 
 
 The Medical Dictionary for Regulatory Activities (MedDRA) version 21.1 or later will be 
used to code all events categorized as adverse events, disease-related events, 
endpoints, to a system organ class and a preferred term. 
The subject incidence of adverse events will be summarized for all treatment-emergent 
adverse events, serious adverse events, adverse events leading to withdrawal of 
investigational product, fatal adverse events, and adverse events of interest.   
Subject incidence of all treatment-emergent adverse events, serious adverse events, 
treatment-related serious and non-serious adverse events, disease-related events, 
adverse events leading to withdrawal of investigational product, and fatal adverse events 
will be tabulated by system organ class and preferred term in alphabetical order.   
Summaries of treatment-emergent and serious adverse events occurring in at 
least 5% of the subjects by preferred term in any treatment arm will be provided in 
descending order of frequency.   
Summaries of treatment-emergent and serious adverse events will be tabulated by 
system organ class, preferred term, and grade.  
9.6.3 
Laboratory Test Results 
Shift tables of the laboratory toxicity based in CTCAE grade will be tabulated by 
treatment group. Subject listing of grades ≥2 laboratory toxicities will be provided. 
In the cases when CTCAE grading scales include numeric range in combination 
with clinical assessment (eg Potassium [Hypokalemia]), laboratory test results 
may be summarized based on standard normal ranges or by CTCAE grade 
utilizing investigator’s input. 
Summary of change from baseline in selected lab analyst will also be provided.  
Subject incidence of liver function test abnormalities (including AST, ALT, Total Bilirubin 
(TBL) and Alkaline Phosphatase (ALP)) will also be summarized by treatment group.  
Additional liver test summary table will provide the number and percentage of subjects 
by treatment group for the following categories:  
 
AST and ALT (> 3x ULN; > 5x ULN; > 10x ULN; > 20x ULN, respectively)  
 
AST or ALT (> 3x ULN; > 5x ULN; > 10x ULN; > 20x ULN, respectively)  
 
Total Bilirubin (> 1x ULN; >1.5x ULN; >2x ULN, respectively)  
 
ALP (>1.5 ULN)  
 
ALT or AST > 3x ULN and Total Bili ≥ 2x ULN and ALP < 2x ULN  


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 55 of 82 
 
 
CONFIDENTIAL 
 
Subject incidence of elevated HbA1c >=6.0% over the DBTP and safety follow-up period 
will also be summarized by treatment group. 
9.6.4 
Vital Signs 
The analyses of vital signs (systolic/diastolic blood pressure, heart rate, temperature and 
respiratory rate) will include summary statistics of change from baseline over time by 
treatment group.   
Systolic and diastolic blood pressure will also be analyzed by change from 
baseline in categories: ≥ 20 mm Hg in SBP for SBP >140 mm Hg (Yes vs. No) 
and ≥ 10 mm Hg in DBP for DBP>90 mm Hg (Yes vs. No) at each time point. 
The number and percentage of subjects with at least one post-treatment vital sign 
measurement meeting any of the following criteria will be reported: 
 
Systolic Blood Pressure: < 90 mm Hg, > 140 mm Hg, > 160mm Hg 
 
Diastolic Blood Pressure: < 50 mm Hg, > 90 mm Hg, > 100 mm Hg 
 
Pulse Rate: < 60 bpm, > 100 bpm 
 
Temperature: > 38.0°C, < 36.0°C 
 
Respiratory rate: < 12 breaths/min, > 20 breaths/min 
9.6.5 
Beck Depression Inventory (BDI)-II 
No statistical testing will be performed on BDI-II. The number and percentage of subjects 
in each of the 4 severity grade categories will be provided by treatment group. 
 
9.6.6 
Columbia Suicide Severity Rating Score (C-SSRS)  
No statistical testing will be performed on C-SSRS. The number and percentage of 
subjects in each of the 5 categories describing suicidal behavior and ideation will be 
summarized by treatment group. 
9.6.7 
Physical Measurements 
The analyses of weight will include summary statistics over time by treatment group. The 
number and percentage of subjects with at least one post-treatment weight 
measurement meeting the following criteria will be reported: 
Decrease of 7% from baseline or increase of 7% from baseline 
9.6.8 
Electrocardiogram 
The ECG measurements from this clinical study will be performed as per standard of 
care for routine safety monitoring, rather than for purposes of assessment of potential 
QTc effect.  Since these evaluations may not necessarily be performed under the 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 56 of 82 
 
 
CONFIDENTIAL 
 
rigorous conditions expected to lead to meaningful evaluation of QTc data, summaries 
and statistical analyses of ECG measurements are not planned, and these data would 
not be expected to be useful for meta-analysis with data from other studies.   
9.6.9 
Antibody Formation 
The number and percentage of subjects who develop anti-AMG 301 antibodies 
(binding) will be tabulated by treatment group for entire study. The list of subjects 
with positive binding antibody at any time will be provided. 
9.6.10 
Exposure to Investigational Product 
The total dose of investigational product and the proportion of subjects receiving each 
dose level will be summarized using descriptive statistics. Descriptive statistics will be 
produced to describe the exposure to investigational product by treatment group. The 
number and percentage of subjects with dose change, reason for dose change and 
duration of exposure to IP in days will be summarized by treatment group. 
9.6.11 
Exposure to Concomitant Medication 
Number and proportion of subjects receiving acute headache-related will be summarized 
by acute medication category for each treatment group.  
9.6.12 
Exposure to Prior Prophylactic Medication 
 Number and percentage of subjects receiving prior prophylactic medication by 
categories and discontinuation reasons will be summarized by treatment group. 
9.6.13 
Cardiovascular Medical History 
Number and proportion of subjects reporting cardioscular medical history will be 
summarized by treatment group. 
9.6.14 
Cardiac and Diabetes Risk Factors 
Number and proportion of subjects reporting cardiac and diabetes risk factors will 
be summarized by treatment group. 
9.7 
Other Analyses 
9.7.1 
Analyses of Pharmacokinetic or Pharmacokinetic/Pharmacodynamic 
Endpoints 
The pharmacokinetic analysis will be carried out for all subjects who received any AMG 
301 doses for estimation of exposure parameters. The exposure parameters will be 
summarized by dose level and treatment time with descriptive statistics. Actual dose and 
actual sampling time will be used in the analysis. Dosing interruptions, sampling errors 


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 58 of 82 
 
 
CONFIDENTIAL 
 
10. 
Changes From Protocol-specified Analyses 
The endpoint of change from the baseline period in monthly days with impact on 
everyday activities as measured by the MPFID domain at assessment time points was 
not included in the protocol but was added to the SAP to assess the effect of AMG 301 
compared to placebo on change from the baseline period in monthly days with impact on 
everyday activities as measured by the MPFID domain.   
The protocol stated that for secondary endpoints comparison between treatment groups 
for categorical data will be performed using generalized linear mixed effects model on 
observed data adjusting for baseline values and stratification factors with appropriate 
contrasts for pairwise comparisons as well as CMH test. The analysis method will be 
changed so that comparison between treatment groups for secondary endpoints will be 
performed using only CMH tests on observed data with stratification factors for 
categorical data. 
The protocol stated that the FAS consists of all subjects who were enrolled in the study.  
This definition will be changed so that the FAS consists of all subjects who were 
randomized in the study. 
Three subgroups were added: prior use of anti-CGRP medication, CAPS score at 
baseline, and response status to AMG 334. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 59 of 82 
 
 
CONFIDENTIAL 
 
11. 
Literature Citations / References 
AMG 301 Investigator Brochure.  Thousand Oaks, CA.  Amgen Inc. 
Afridi SK, Giffin NJ, Kaube H, et al.  A positron emission tomographic study in 
spontaneous migraine.  Arch Neurol 2005;62:1270-1275. 
Amgen.  A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate 
the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention.  AMG 334 Study 
20120295.  23 July 2015.  
Amgen.  A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate 
the Efficacy and Safety of AMG 334 in Migraine Prevention.  AMG 334 Study 20120296.  
24 March 2015.  
Aurora SK, Barrodale P, Chronicle EP, Mulleners WM.  Cortical inhibition is reduced in 
chronic and episodic migraine and demonstrates a spectrum of illness.  Headache 
2005;45:546-52. 
Aurora SK, Wilkinson F.  The brain is hyperexcitable in migraine.  Cephalalgia 
2007;27:1442-14453. 
Edvinsson L. Role of VIP/PACAP in primary headaches.  Cephalalgia 
2013;33:1070-1072. 
Eftekhari S, Salvatore CA, Johansson S, Chen TB, Zeng Z, Edvinsson L.  Localization of 
CGRP, CGRP receptor, PACAP and glutamate in trigeminal ganglion.  Relation to the 
blood-brain barrier.  Brain Res 2015;1600:93-109. 
Goadsby PJ, Lipton RB, Ferrari MD.  Migraine – current understanding and treatment.  N 
Engl J Med. 2002;364(4):257-270. 
Headache Classification Committee of the International Headache Society (IHS).  The 
International Classification of Headache Disorders, 3rd edition (beta version).  
Cephalalgia. 2013;33(9):629-808. 
Katsarava Z, Buse D, Manack A, Lipton R.  Defining the differences between episodic 
migraine and chronic migraine.  Curr Pain Headache Rep.  2012;16:86-92. 
Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the 
need for preventive therapy.  Neurology 2007;68:343-349. 
Rahmann A, Wienecke T, Hansen JM, Fahrenkrug J, Olesen J, Ashina M.  Vasoactive 
intestinal peptide causes marked cephalic vasodilation, but does not induce migraine.  
Cephalalgia 2008;28:226-236. 
Riesco N, Perez-Alvarex A, Verano C, Garcia-Cabo C, Martinez-Ramos J, 
Sanchez-Lozano P.  Prevalence of cranial autonomic parasympathetic symptoms in 
chronic migraine:  Usefulness of a new scale.  Cephalalgia 2016;36:346-350. 
Robbins MS, Lipton RB.  The epidemiology of primary headache disorders. 
Semin Neurol. 2010;30:107-119. 
Schytz HW, Birk S, Wienecke T, Kruuse C, Olesen J, Ashina M.  PACAP38 induces 
migraine-like attacks in patients with migraine without aura.  Brain 2009;132:16-25. 
Schytz HW, Olesen J, Ashina M.  The PACAP receptor: a novel target for migraine 
treatment. Neurotherapeutics 2010;7:191-196. 
Stovner LJ, Andree C.  Prevalence of headache in Europe:  a review for the Eurolight 
project.  J Headache Pain.  2010;11(4):289-299. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
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United States Food and Drug Administration.  Guidance for Industry Drug-Induced Liver 
Injury: Premarketing Clinical Evaluation.  July 
2009.  http://www.fda.gov/downloads/Drugs/.../Guidances/UCM174090.pdf.  Accessed 
19 November 2012. 
Vaudry D, Falluel-Morel A, Bourgault S, et al.  Pituitary adenylate cyclase-activating 
polypeptide and its receptors: 20 years after the discovery.  Pharmacol Rev 
2009;61:283-357. 
Welch KM, Nagesh V, Aurora SK, Gelman N.  Periaqueductal gray matter dysfunction in 
migraine: cause or the burden of illness.  Headache 2001;41:629-637. 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 61 of 82 
 
 
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12. 
Prioritization of Analyses 
There is no prioritization for these analyses. 


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Protocol Number:  20150308 
Date:  31 October 2018 
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CONFIDENTIAL 
 
14. 
Appendices 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
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CONFIDENTIAL 
 
Appendix A.  Technical Detail and Information Regarding Statistical Procedures 
and Programming 
 
N/A 
 


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 71 of 82 
 
 
CONFIDENTIAL 
 
 
Appendix C.  Reference Values/Toxicity Grades 
Adverse event severity and laboratory toxicity are graded based on NCI Common 
Toxicity Criteria version 4 or higher, which is available at the following: 
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 72 of 82 
 
 
CONFIDENTIAL 
 
 
Appendix D.  Concomitant Medications 
 
N/A 
 


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Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 81 of 82 
 
 
CONFIDENTIAL 
 
 
Appendix F.  Health Economic Forms/Instruments 
N/A 


Product:  AMG 301 
Protocol Number:  20150308 
Date:  31 October 2018 
Page 82 of 82 
 
 
CONFIDENTIAL 
 
 
Appendix G.  Details of PK or PK/PD Methods for Modeling 
N/A