Clinical trial NCT03238781: Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Official title: A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Migraine or Episodic Migraine
Keywords: Migraine
Headache
Prevention
Prophylaxis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2017-08-03
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.
* History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013)
* Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening.
* Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy

Exclusion Criteria:

* Older than 50 years of age at migraine onset.
* History of cluster headache, hemiplegic migraine headache.
* Unable to differentiate migraine from other headaches.
* Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.
* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Primary outcomes:
measure: Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period
timeFrame: Baseline Day -28 to Day -1; Weeks 9-12
Secondary outcomes:
measure: Percentage of Participants Who Responded, Defined as 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
timeFrame: Baseline Day -28 to Day -1; Weeks 9-12
measure: Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period
timeFrame: Baseline Day -28 to Day -1; Weeks 9-12
measure: Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period
timeFrame: Baseline Day -28 to Day -1; Weeks 9-12
measure: Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period
timeFrame: Baseline Day -28 to Day -1; Weeks 9-12
measure: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to Week 30 (12 weeks of double-blind treatment plus 18 weeks follow-up after last dose of investigational product)
measure: Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study
timeFrame: Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28
measure: Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study
timeFrame: Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28
measure: Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study
timeFrame: Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28
measure: Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit
timeFrame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
measure: Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit
timeFrame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
measure: Percentage of Participants With Pulse Rate in Categories by Visit
timeFrame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
measure: Percentage of Participants With Temperature in Categories by Visit
timeFrame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
measure: Percentage of Participants With Respiratory Rates in Categories by Visit
timeFrame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Boulder
country: United States
facility: Research Site
state: Colorado
city: East Hartford
country: United States
facility: Research Site
state: Connecticut
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Saint Peters
country: United States
facility: Research Site
state: Missouri
city: Plainview
country: United States
facility: Research Site
state: New York
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Innsbruck
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Levis
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Brno
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Prerov
country: Czechia
facility: Research Site
city: Aarhus
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Jyvaskyla
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Ashina M, Dolezil D, Bonner JH, Zhou L, Klatt J, Picard H, Mikol DD. A phase 2, randomized, double-blind, placebo-controlled trial of AMG 301, a pituitary adenylate cyclase-activating polypeptide PAC1 receptor monoclonal antibody for migraine prevention. Cephalalgia. 2021 Jan;41(1):33-44. doi: 10.1177/0333102420970889. Epub 2020 Nov 24.