Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
NCT ID: NCT03238781
Last Updated: 2020-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
343 participants
INTERVENTIONAL
2017-09-06
2019-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo
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.
Placebo
Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.
AMG 301 210 mg Q4W
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.
AMG 301
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 301 420 mg Q2W
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.
AMG 301
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.
Interventions
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Placebo
Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.
AMG 301
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Long Beach, California, United States
Research Site
Santa Monica, California, United States
Research Site
Boulder, Colorado, United States
Research Site
East Hartford, Connecticut, United States
Research Site
Stamford, Connecticut, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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City of Saint Peters, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Plainview, New York, United States
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Greensboro, North Carolina, United States
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Cleveland, Ohio, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Round Rock, Texas, United States
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Salt Lake City, Utah, United States
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Innsbruck, , Austria
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Klagenfurt, , Austria
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Vienna, , Austria
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Calgary, Alberta, Canada
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Surrey, British Columbia, Canada
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Markham, Ontario, Canada
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Toronto, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Přerov, , Czechia
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Aarhus, , Denmark
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Glostrup Municipality, , Denmark
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Viborg, , Denmark
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Helsinki, , Finland
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Helsinki, , Finland
Research Site
Jyväskylä, , Finland
Research Site
Oulu, , Finland
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Turku, , Finland
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Berlin, , Germany
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Berlin, , Germany
Research Site
Hamburg, , Germany
Research Site
Kiel, , Germany
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Leipzig, , Germany
Research Site
Stockholm, , Sweden
Research Site
Stockholm, , Sweden
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2017-000630-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20150308
Identifier Type: -
Identifier Source: org_study_id
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