Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
261 participants
INTERVENTIONAL
2019-04-12
2020-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
NCT03867201
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention
NCT02483585
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
NCT02066415
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
NCT02456740
A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention
NCT02630459
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study consists of a screening period (up to 7 weeks, including a 4-week baseline period), a 24-week double-blind treatment period (DBTP), a 28-week open-label treatment period (OLTP), and an 8-week safety follow-up period (12 weeks after the last dose of investigational product).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Erenumab
Participants were to receive erenumab 70 mg once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
Erenumab
Administered by subcutaneous injection once a month
Placebo
Participants were to receive placebo to erenumab once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
Erenumab
Administered by subcutaneous injection once a month
Placebo
Administered by subcutaneous injection once a month
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Erenumab
Administered by subcutaneous injection once a month
Placebo
Administered by subcutaneous injection once a month
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age upon entry into screening.
* History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report
* Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months before screening based on the following criteria:
1. CM is defined as greater than or equal to 15 headache days per month of which greater than or equal to 8 headache days on average across the 3 months meet criteria as migraine days
2. EM is defined as less than 15 headache days per month of which at least 4 or more headache days on average across the 3 months meet criteria as migraine days
Exclusion Criteria
* History of cluster headache or 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.
* Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
20 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Matsuyama, Ehime, Japan
Research Site
Kasuga-shi, Fukuoka, Japan
Research Site
Kasuga-shi, Fukuoka, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kahoku-gun, Ishikawa-ken, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Takamatsu, Kagawa-ken, Japan
Research Site
Kagoshima, Kagoshima-ken, Japan
Research Site
Kawasaki-shi, Kanagawa, Japan
Research Site
Kawasaki-shi, Kanagawa, Japan
Research Site
Kochi, Kochi, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Ōita, Oita Prefecture, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Toyonaka-shi, Osaka, Japan
Research Site
Saga, Saga-ken, Japan
Research Site
Iruma-gun, Saitama, Japan
Research Site
Saitama-shi, Saitama, Japan
Research Site
Tokorozawa-shi, Saitama, Japan
Research Site
Shizuoka, Shizuoka, Japan
Research Site
Shimotsuga-gun, Tochigi, Japan
Research Site
Chofu-shi, Tokyo, Japan
Research Site
Hachioji-shi, Tokyo, Japan
Research Site
Minato-ku, Tokyo, Japan
Research Site
Minato-ku, Tokyo, Japan
Research Site
Shibuya-ku, Tokyo, Japan
Research Site
Shinjuku-ku, Tokyo, Japan
Research Site
Tottori-shi, Tottori, Japan
Research Site
Yonago-shi, Tottori, Japan
Research Site
Toyama, Toyama, Japan
Research Site
Hofu-shi, Yamaguchi, Japan
Research Site
Yamaguchi, Yamaguchi, Japan
Research Site
Kai-shi, Yamanashi, Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Hirata K, Takeshima T, Sakai F, Imai N, Matsumori Y, Tatsuoka Y, Numachi Y, Yoshida R, Peng C, Mikol DD, Lima GPDS, Cheng S. Early onset of efficacy with erenumab for migraine prevention in Japanese patients: Analysis of two randomized, double-blind, placebo-controlled studies. Brain Behav. 2022 Mar;12(3):e2526. doi: 10.1002/brb3.2526. Epub 2022 Feb 24.
Hiramatsu K, Onizuka Y, Hasebe M, Yoshida R, Numachi Y. Novel Drug for Migraine Prophylaxis: Mode of Action, Efficacy and Safety of Erenumab. Shinryo to Shinyaku (Med Cons New-Remed) 2021:58(11):797-832
Hirata K, Sakai F, Takeshima T, Imai N, Matsumori Y, Yoshida R, Numachi Y, Peng C, Mikol DD, Cheng S. Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial. J Headache Pain. 2021 Sep 18;22(1):110. doi: 10.1186/s10194-021-01313-8.
Takeshima T, Sakai F, Hirata K, Imai N, Matsumori Y, Yoshida R, Peng C, Cheng S, Mikol DD. Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study. Headache. 2021 Jun;61(6):927-935. doi: 10.1111/head.14138. Epub 2021 Jun 21.
Hirata K, Takeshima T, Sakai F, Numachi Y, Yoshida R, Koukakis R, Hasebe M, Yui D, da Silva Lima GP, Cheng S. Long-term efficacy and safety of erenumab in Japanese patients with episodic and chronic migraine: results from a 28-week open-label treatment period of a randomised trial. BMJ Open. 2023 Aug 18;13(8):e068616. doi: 10.1136/bmjopen-2022-068616.
Kitamura S, Takeshima T, Yui D, da Silva Lima GP, Koukakis R, Peng C, Yoshida R, Numachi Y, Hasebe M. Efficacy of Erenumab for Migraine Prevention in Japanese Patients with Episodic and Chronic Migraine: Results of a Post-Hoc Pooled Analysis. Neurol Ther. 2023 Dec;12(6):1993-2006. doi: 10.1007/s40120-023-00538-w. Epub 2023 Sep 12.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20170609
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.