Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

NCT ID: NCT05399485

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 496 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2024-11-07

Brief Summary

This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.

Conditions

Migraine

Study Design

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

Study Groups

Rimegepant

Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12

Group Type: EXPERIMENTAL

Rimegepant

Intervention Type: DRUG

Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12

Placebo

Randomization Phase: one matching placebo every other day until week 12

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12

Interventions

Rimegepant

Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12

Intervention Type: DRUG

Placebo

Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12

Intervention Type: DRUG

Other Intervention Names

BHV3000

Eligibility Criteria

Inclusion Criteria

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

1. Age of onset of migraines prior to 50 years of age.

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

3. Per subject report, 4 to18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol).

4. 4 or more migraine days during Observation Period.

5. Not more than 18 headache days during the Observation Period.

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

7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Observation Period, and 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. Subjects with headaches occurring 19 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit.

3. History of systemic 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.

4. Subject with a history of HIV disease.

5. 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.

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

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

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

9. 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.

10. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.

11. 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

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 Clinic Internal Medicine/Neurology

Hiroshima, Hiroshima, Japan

Japanese Red Cross Asahikawa Hospital

Asahikawa-shi, Hokkaido, Japan

Nakamura Memorial Hospital

Chūōku, Hokkaido, Japan

Higashi Sapporo Neurology and Neurosurgery Clinic

Sapporo, Hokkaido, Japan

Konan Medical Center

Higashinada-ku, Hyōgo, Japan

Nishinomiya Munic. Ctr. Hosp.

Nishinomiya-shi, Hyōgo, Japan

Mito Kyodo General Hospital

Mito, Ibaraki, Japan

Kijima Neurosurgery Clinic

Kahoku-gun, Ishikawa-ken, Japan

Iwate Medical University Uchimaru Medical Center

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

Tatsuoka Neurology Clinic

Kyoto, Kyoto, Japan

Sendai Headache and Neurology Clinic, Medical Corporation

Sendai, Miyagi, Japan

Ooba Clinic for Neurosurgery & Headache

Ōita, Oita Prefecture, Japan

Makabe Clinic

Okayama, Okayama-ken, Japan

Okayama City General Medical Center Okayama City Hospital

Okayama, Okayama-ken, Japan

Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

Osaka, Osaka, Japan

Tominaga Clinic

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

Saitama Neuropsychiatric Institute

Saitama-shi, Saitama, Japan

Japanese Red Cross Shizuoka Hospital

Shizuoka, Shizuoka, Japan

Dokkyo Medical Univ. Hosp.

Shimotsuga-gun, Tochigi, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Tokai univ. hachioji hosp.

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

Fukuuchi Pain Clinic

Shinjuku-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Nishiogi Pain Clinic

Suginami-ku, Tokyo, Japan

Sakura Neuro Clinic

Toyama, Toyama, Japan

Nagamitsu Clinic

Hofu-shi, Yamaguchi, Japan

Nagaseki Headache Clinic

Kai-shi, Yamanashi, Japan

Countries

Japan

References

Kitamura S, Matsumori Y, Yamamoto T, 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 preventive treatment of migraine in Japan: A double-blind, randomized controlled trial. Headache. 2025 Sep;65(8):1403-1412. doi: 10.1111/head.14995. Epub 2025 Jun 20.

Reference Type: DERIVED

PMID: 40542538 (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=BHV3000-309

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

Other Identifiers

C4951021

Identifier Type: OTHER

Identifier Source: secondary_id

BHV3000-309

Identifier Type: -

Identifier Source: org_study_id