Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

NCT03238781 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 201503082017-000630-57
• Study Type: interventional
• Target: 343
• Locations: 8 countries
• Sites: 49

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.

Conditions

Chronic Migraine or Episodic Migraine

Keywords

Migraine; Headache; Prevention; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period

  A migraine day is any calendar day from the eDiary in which the participant experienced a migraine headache. A migraine headache is a headache with or without aura, lasting for \>= 4 hours, and meeting \>=1 of the criteria: 1. \>= 2 pain features (unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity) 2. \>= 1 symptoms (nausea and/or vomiting, photophobia and phonophobia) If the participant took a migraine-specific medication during aura or to treat headache, it was counted as a migraine day. Days without eDiary data in each monthly interval are handled by proration. Negative change from baseline values indicated improvement (i.e. fewer migraine days after treatment as compared to baseline).

  Baseline Day -28 to Day -1; Weeks 9-12

Secondary Outcomes (13)

• 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

  Baseline Day -28 to Day -1; Weeks 9-12

• Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period

  Baseline Day -28 to Day -1; Weeks 9-12

• 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

  Baseline Day -28 to Day -1; Weeks 9-12

• 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

  Baseline Day -28 to Day -1; Weeks 9-12

• Participants With Treatment-Emergent Adverse Events (TEAEs)

  Day 1 up to Week 30 (12 weeks of double-blind treatment plus 18 weeks follow-up after last dose of investigational product)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

AMG 301 210 mg Q4W

EXPERIMENTAL

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.

Drug: AMG 301

AMG 301 420 mg Q2W

EXPERIMENTAL

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.

Drug: AMG 301

Interventions

Placebo DRUG

Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.

Placebo

AMG 301 DRUG

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.

AMG 301 210 mg Q4W; AMG 301 420 mg Q2W

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (49)

Research Site

Long Beach, California, 90806, United States

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Santa Monica, California, 90404, United States

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Boulder, Colorado, 80301, United States

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East Hartford, Connecticut, 06118, United States

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Stamford, Connecticut, 06905, United States

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Jacksonville, Florida, 32216, United States

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Orlando, Florida, 32801, United States

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West Palm Beach, Florida, 33407, United States

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Worcester, Massachusetts, 01605, United States

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Ann Arbor, Michigan, 48104, United States

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City of Saint Peters, Missouri, 63303, United States

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St Louis, Missouri, 63141, United States

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Plainview, New York, 11803, United States

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Greensboro, North Carolina, 27405, United States

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Cleveland, Ohio, 44195, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75214, United States

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Round Rock, Texas, 78681, United States

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Salt Lake City, Utah, 84109, United States

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Innsbruck, 6020, Austria

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Klagenfurt, 9020, Austria

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Vienna, 1090, Austria

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Calgary, Alberta, T3M 1M4, Canada

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Surrey, British Columbia, V3Z 2N6, Canada

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Markham, Ontario, L3R 9X3, Canada

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Toronto, Ontario, M4S 1Y2, Canada

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Lévis, Quebec, G6W 0M6, Canada

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Montreal, Quebec, H2W 1V1, Canada

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Brno, 616 00, Czechia

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Prague, 120 00, Czechia

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Prague, 140 59, Czechia

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Přerov, 750 02, Czechia

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Aarhus, 8000, Denmark

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Glostrup Municipality, 2600, Denmark

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Viborg, 8800, Denmark

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Helsinki, 00100, Finland

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Helsinki, 00930, Finland

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Jyväskylä, 40100, Finland

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Oulu, 90220, Finland

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Turku, 20100, Finland

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Berlin, 10117, Germany

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Berlin, 10435, Germany

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Hamburg, 20251, Germany

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Kiel, 24149, Germany

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Leipzig, 04107, Germany

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Stockholm, 112 45, Sweden

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Stockholm, 114 33, Sweden

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Related Publications (1)

• 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.

  PMID: 33231489 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: September 6, 2017
• Primary Completion: October 16, 2018
• Study Completion: February 4, 2019
• Last Updated: February 7, 2020
• Results First Posted: February 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

SE (2); FI (5); CA (6); DE (5); DK (3); CZ (4); AU (3); US (21)