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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03812224
Other study ID # 20170609
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 12, 2019
Est. completion date November 25, 2020

Study information

Verified date February 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

Migraine prevention is an area of a large unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against canonical CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM). 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).


Recruitment information / eligibility

Status Completed
Enrollment 261
Est. completion date November 25, 2020
Est. primary completion date March 16, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - 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: 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: - 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. Other exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Erenumab
Administered by subcutaneous injection once a month
Placebo
Administered by subcutaneous injection once a month

Locations

Country Name City State
Japan Research Site Chofu-shi Tokyo
Japan Research Site Hachioji-shi Tokyo
Japan Research Site Hiroshima-shi Hiroshima
Japan Research Site Hiroshima-shi Hiroshima
Japan Research Site Hofu-shi Yamaguchi
Japan Research Site Iruma-gun Saitama
Japan Research Site Kagoshima-shi Kagoshima
Japan Research Site Kahoku-gun Ishikawa
Japan Research Site Kai-shi Yamanashi
Japan Research Site Kasuga-shi Fukuoka
Japan Research Site Kasuga-shi Fukuoka
Japan Research Site Kawasaki-shi Kanagawa
Japan Research Site Kawasaki-shi Kanagawa
Japan Research Site Kobe-shi Hyogo
Japan Research Site Kochi-shi Kochi
Japan Research Site Kumamoto-shi Kumamoto
Japan Research Site Kumamoto-shi Kumamoto
Japan Research Site Kyoto-shi Kyoto
Japan Research Site Matsuyama-shi Ehime
Japan Research Site Minato-ku Tokyo
Japan Research Site Minato-ku Tokyo
Japan Research Site Morioka-shi Iwate
Japan Research Site Oita-shi Oita
Japan Research Site Osaka-shi Osaka
Japan Research Site Saga-shi Saga
Japan Research Site Saitama-shi Saitama
Japan Research Site Sapporo-shi Hokkaido
Japan Research Site Sapporo-shi Hokkaido
Japan Research Site Sapporo-shi Hokkaido
Japan Research Site Sendai-shi Miyagi
Japan Research Site Shibuya-ku Tokyo
Japan Research Site Shimotsuga-gun Tochigi
Japan Research Site Shinjuku-ku Tokyo
Japan Research Site Shizuoka-shi Shizuoka
Japan Research Site Takamatsu-shi Kagawa
Japan Research Site Tokorozawa-shi Saitama
Japan Research Site Tottori-shi Tottori
Japan Research Site Toyama-shi Toyama
Japan Research Site Toyonaka-shi Osaka
Japan Research Site Yamaguchi-shi Yamaguchi
Japan Research Site Yonago-shi Tottori

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

Japan, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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:
= 2 of the following pain features:
unilateral
throbbing
moderate to severe
exacerbated with exercise/physical activity
= 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 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 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:
= 2 of the following pain features:
unilateral
throbbing
moderate to severe
exacerbated with exercise/physical activity
= 1 of the following associated symptoms:
nausea
vomiting
photophobia and phonophobia
4-week baseline period and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period
Secondary Change From Baseline in Mean Monthly Acute Migraine-specific Medication Treatment Days Over Months 4, 5, and 6 of the DBTP An acute migraine-specific medication treatment day is any calendar day during which a participant took a migraine-specific medication (e.g., triptan or ergotamine).
The change from baseline in monthly acute migraine-specific treatment days was calculated as the average number of migraine-specific treatment days per month during the last 3 months of the 24-week double-blind treatment period minus the number of migraine-specific treatment 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
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