A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Phase: PHASE2
Conditions: Chronic Migraine or Episodic Migraine
Sponsor: Amgen

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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