A Controlled Trial of Erenumab in Migraine Prevention

NCT03812224 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20170609
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 41

Brief Summary

The purpose of this study was to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Monthly Migraine Days (MMD) Over Months 4, 5, and 6 of the Double-blind Treatment Period

  A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura, lasting for ≥ 4 hours, and meeting at least 1 of the following criteria: 1. ≥ 2 of the following pain features: * unilateral * throbbing * moderate to severe * exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: * nausea * vomiting * photophobia and phonophobia The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period minus the number of migraine days during the 4-week baseline period.

  4-week baseline period and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period

Secondary Outcomes (2)

• Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days Over Months 4, 5, and 6 of the DBTP

  4-week baseline period and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period

• Change From Baseline in Mean Monthly Acute Migraine-specific Medication Treatment Days Over Months 4, 5, and 6 of the DBTP

  4-week baseline period and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period

Study Arms (2)

Erenumab

EXPERIMENTAL

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.

Drug: Erenumab

Placebo

PLACEBO COMPARATOR

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.

Drug: Erenumab; Drug: Placebo

Interventions

Erenumab DRUG

Administered by subcutaneous injection once a month

Also known as: AMG 334, Aimovig®

Erenumab; Placebo

Placebo DRUG

Administered by subcutaneous injection once a month

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
• 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:
• 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
• 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

You may not qualify if:

• Subjects greater than 50 years of age at migraine onset.
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (41)

Research Site

Matsuyama, Ehime, 790-0925, Japan

Location

Research Site

Kasuga-shi, Fukuoka, 816-0802, Japan

Location

Research Site

Kasuga-shi, Fukuoka, 816-0824, Japan

Location

Research Site

Hiroshima, Hiroshima, 730-0031, Japan

Location

Research Site

Hiroshima, Hiroshima, 730-0845, Japan

Location

Research Site

Sapporo, Hokkaido, 003-0003, Japan

Location

Research Site

Sapporo, Hokkaido, 007-0836, Japan

Location

Research Site

Sapporo, Hokkaido, 060-8570, Japan

Location

Research Site

Kobe, Hyōgo, 658-0064, Japan

Location

Research Site

Kahoku-gun, Ishikawa-ken, 929-0342, Japan

Location

Research Site

Morioka, Iwate, 020-8505, Japan

Location

Research Site

Takamatsu, Kagawa-ken, 769-0103, Japan

Location

Research Site

Kagoshima, Kagoshima-ken, 892-0844, Japan

Location

Research Site

Kawasaki-shi, Kanagawa, 211-8588, Japan

Location

Research Site

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

Research Site

Kochi, Kochi, 780-8011, Japan

Location

Research Site

Kumamoto, Kumamoto, 861-2101, Japan

Location

Research Site

Kumamoto, Kumamoto, 862-8505, Japan

Location

Research Site

Kyoto, Kyoto, 600-8811, Japan

Location

Research Site

Sendai, Miyagi, 982-0014, Japan

Location

Research Site

Ōita, Oita Prefecture, 870-0831, Japan

Location

Research Site

Osaka, Osaka, 556-0017, Japan

Location

Research Site

Toyonaka-shi, Osaka, 560-0012, Japan

Location

Research Site

Saga, Saga-ken, 840-0806, Japan

Location

Research Site

Iruma-gun, Saitama, 350-0495, Japan

Location

Research Site

Saitama-shi, Saitama, 338-8577, Japan

Location

Research Site

Tokorozawa-shi, Saitama, 359-1141, Japan

Location

Research Site

Shizuoka, Shizuoka, 420-0853, Japan

Location

Research Site

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Research Site

Chofu-shi, Tokyo, 182-0006, Japan

Location

Research Site

Hachioji-shi, Tokyo, 192-0032, Japan

Location

Research Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Research Site

Minato-ku, Tokyo, 108-8642, Japan

Location

Research Site

Shibuya-ku, Tokyo, 151-0051, Japan

Location

Research Site

Shinjuku-ku, Tokyo, 160-0017, Japan

Location

Research Site

Tottori-shi, Tottori, 680-0045, Japan

Location

Research Site

Yonago-shi, Tottori, 683-0033, Japan

Location

Research Site

Toyama, Toyama, 930-0803, Japan

Location

Research Site

Hofu-shi, Yamaguchi, 747-0802, Japan

Location

Research Site

Yamaguchi, Yamaguchi, 754-0002, Japan

Location

Research Site

Kai-shi, Yamanashi, 400-0124, Japan

Location

Related Publications (7)

• 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.

  PMID: 35272533 BACKGROUND

• 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.

  PMID: 35201674 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34537006 BACKGROUND

• 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.

  PMID: 34153117 BACKGROUND

• 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.

  PMID: 37597868 BACKGROUND

• 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.

  PMID: 37698837 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: April 12, 2019
• Primary Completion: March 16, 2020
• Study Completion: November 25, 2020
• Last Updated: February 21, 2024
• Results First Posted: March 4, 2021

Record last verified: 2024-02

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

JP (41)