Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention
NCT ID: NCT02483585
Last Updated: 2022-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
577 participants
INTERVENTIONAL
2015-07-20
2017-03-20
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
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase.
Placebo
Administered once a month by subcutaneous injection
Erenumab
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase.
Erenumab
Administered once a month by subcutaneous injection
Interventions
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Erenumab
Administered once a month by subcutaneous injection
Placebo
Administered once a month by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Migraine frequency: ≥ 4 and \< 15 migraine days per month on average acrossthe 3 months prior to screening
* Headache (ie, migraine and non-migraine headache) frequency: \< 15 headache days per month on average across the 3 months prior to screening
* Demonstrated compliance with the eDiary
Exclusion Criteria
* History of cluster headache or hemiplegic migraine headache.
* Unable to differentiate migraine from other headaches
* No therapeutic response with \> 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial.
* Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study
* Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase.
* Received botulinum toxin
* Anticipated to require any excluded medication, device, or procedure during the study.
* Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain).
* History of major psychiatric disorder.
* History of seizure disorder or other significant neurological conditions other than migraine.
* Human immunodeficiency virus (HIV) infection by history.
* Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening.
* The subject is at risk of self-harm or harm to others. Previously randomized into an AMG 334 study.
* Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
18 Years
65 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
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Culver City, California, United States
Research Site
Long Beach, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
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Santa Monica, California, United States
Research Site
Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Oviedo, Florida, United States
Research Site
Palm Beach Gardens, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Gurnee, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Lenexa, Kansas, United States
Research Site
Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Kalamazoo, Michigan, United States
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Princeton, New Jersey, United States
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Albuquerque, New Mexico, United States
Research Site
Williamsville, New York, United States
Research Site
Asheville, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Warwick, Rhode Island, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Virginia Beach, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Glostrup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Bordeaux, , France
Research Site
Nice, , France
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Paris, , France
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Paris, , France
Research Site
Pringy, , France
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Amadora, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Torres Vedras, , Portugal
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Ufa, , Russia
Research Site
Zaragoza, Aragon, Spain
Research Site
Santander, Cantabria, Spain
Research Site
Valladolid, Castille and León, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Santiago de Compostela, Galicia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Madrid, , Spain
Research Site
Bad Zurzach, , Switzerland
Research Site
Biel, , Switzerland
Research Site
Geneva, , Switzerland
Research Site
Lugano, , Switzerland
Research Site
Sankt Gallen, , Switzerland
Research Site
Zollikon, , Switzerland
Countries
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References
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Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.
Cheng S, Picard H, Zhang F, Eisele O, Mikol DD. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache. 2019; 45 : 493-505.
Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10.
Kawata AK, Ladd MK, Lipton RB, Buse DC, Bensink M, Shah S, Hareendran A, Mannix S, Mikol D. Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials. Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.
Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.
Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18.
Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2014-004463-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120297
Identifier Type: -
Identifier Source: org_study_id
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