Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

NCT ID: NCT05399459

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 897 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2024-01-19

Brief Summary

This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment of migraine.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rimegepant 25 mg

Single dose of 25 mg orally disintegrating tablet of rimegepant

Group Type: EXPERIMENTAL

Rimegepant 25 MG

Intervention Type: DRUG

Single dose of 25 mg orally disintegrating tablet of rimegepant

Rimegepant 75 mg

Single dose of 75 mg orally disintegrating tablet of rimegepant

Group Type: EXPERIMENTAL

Rimegepant 75 MG

Intervention Type: DRUG

Single dose of 75 mg orally disintegrating tablet of rimegepant

Placebo

Matching placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo tablet

Interventions

Rimegepant 25 MG

Single dose of 25 mg orally disintegrating tablet of rimegepant

Intervention Type: DRUG

Rimegepant 75 MG

Single dose of 75 mg orally disintegrating tablet of rimegepant

Intervention Type: DRUG

Placebo

Matching placebo tablet

Intervention Type: DRUG

Other Intervention Names

BHV3000; BHV3000

Eligibility Criteria

Inclusion Criteria

Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, including the following:

1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.

2. Migraine attacks, on average, lasting about 4-72 hours if untreated.

3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months.

4. Ability to distinguish migraine attacks from tension/cluster headaches.

5. Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to Screening Visit and maintains this requirement during the Screening period.

6. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to Screening Visit and maintains this requirement during the Screening Period.

7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months prior to the Screening Visit, and if the dose is not expected to change during the course of the study.

8. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Exclusion Criteria

1. Subject has a history of migraine with brainstem aura (basilar migraine), hemiplegic migraine or retinal migraine.

2. History of use of analgesics (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.

3. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.

4. Uncontrolled hypertension or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).

5. Subject with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments.

6. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that causes malabsorption.

7. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.

8. History of alcohol abuse and/or illicit drug use meeting DSM-V criteria for substance use disorder within 6 months of screening.

9. Participation in any other investigational clinical trial while participating in this clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Tokyo Dental College Ichikawa General Hospital

Ichikawa-shi, Chiba, Japan

Medical Corporation Seikokai Takanoko Hospital

Matsuyama, Ehime, Japan

Jinnouchi Neurosurgical Clinic

Kasuga-shi, Fukuoka, Japan

Ikeda Neurosurgical Clinic

Kasuga-shi, Fukuoka, Japan

SUBARU Health Insurance Society Ota Memorial Hospital

Ota-shi, Gunma, Japan

DOI CL Intern. Med./Neurol.

Hiroshima, Hiroshima, Japan

Japanese Red Cross Asahikawa Hospital

Asahikawa-shi, Hokkaido, Japan

Higashi Sapporo Neurology and Neurosurgery Clinic

Sapporo, Hokkaido, Japan

Nakamura Memorial Hospital

Sapporo, Hokkaido, Japan

Konan Medical Center

Kobe, Hyōgo, Japan

Nishinomiya Municipal Central Hospital

Nishinomiya-shi, Hyōgo, Japan

Mito Kyodo General Hospital

Mito, Ibaraki, Japan

Kijima Neurosurgery Clinic

Kahoku-gun, Ishikawa-ken, Japan

Iwate Med. Univ. Uchimaru MC

Morioka, Iwate, Japan

Atsuchi Neurosurgery Hospital

Kagoshima, Kagoshima-ken, Japan

Tanaka Neurosurgical Clinic

Kagoshima, Kagoshima-ken, Japan

St. Marianna Univ. Hospital

Kawasaki-shi, Kanagawa, Japan

Fujitsu Clinic

Nakahara, Kanagawa, Japan

Atago Hospital

Kochi, Kochi, Japan

Umenotsuji Clinic

Kochi, Kochi, Japan

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Kyoto Okamoto Memorial Hospital

Kumiyama-cho, Kyoto, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Ishikawa Clinic

Sakyo-ku, Kyoto, Japan

Tatsuoka Neurology Clinic

Shimogyo-ku, Kyoto, Japan

Narikawa Neurological Clinic

Izumi-ku, Miyagi, Japan

Sendai Headache and Neurology Clinic, Medical Corporation

Sendai, Miyagi, Japan

Ooba CL Neurosurg. & Headache

Ōita, Oita Prefecture, Japan

Makabe Clinic

Okayama, Okayama-ken, Japan

Okayama City General Medical Center Okayama City Hospital

Okayama, Okayama-ken, Japan

Tominaga Clinic

Naniwa-ku, Osaka, Japan

Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

Osaka, Osaka, Japan

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

Takase Intern. Med. Clinic

Toyonaka-shi, Osaka, Japan

Saitama Medical University Hospital

Iruma-gun, Saitama, Japan

JRC Shizuoka Hospital

Shizuoka, Shizuoka, Japan

Dokkyo Medical Univ. Hosp.

Shimotsuga-gun, Tochigi, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Tokai university hachioji hospital

Hachioji-shi, Tokyo, Japan

Shinagawa Strings Clinic

Minato-ku, Tokyo, Japan

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

USUDA CLINIC for internal medicine

Setagaya-ku, Tokyo, Japan

Tokyo Headache Clinic

Shibuya-Ku, Tokyo, Japan

Fukuuchi Pain Clinic

Shinjuku-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Nishiogi Pain Clinic

Suginami-ku, Tokyo, Japan

Suzuki Kei Yasuragi clinic

Tachikawa, Tokyo, Japan

Sakura Neuro Clinic

Toyama, Toyama, Japan

Nagamitsu Clinic

Hofu-shi, Yamaguchi, Japan

Nagaseki Headache Clinic

Kai-shi, Yamanashi, Japan

Countries

Japan

References

Ikeda K, Matsumori Y, Kudo M, Ishikawa T, Hoshino Y, Yoshimatsu H, Thiry A, Arakawa A, Croop R, Fullerton T, Sakai F, Takeshima T. Efficacy and safety of rimegepant for the acute treatment of migraine in Japan: A dose-ranging, double-blind, randomized controlled trial. Headache. 2025 Jun 30. doi: 10.1111/head.14994. Online ahead of print.

Reference Type: DERIVED

PMID: 40586377 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-313

To obtain contact information for a study center near you, click here.

Other Identifiers

C4951022

Identifier Type: OTHER

Identifier Source: secondary_id

BHV3000-313

Identifier Type: -

Identifier Source: org_study_id