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

Last updated: November 3, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Migraine (Adult)

Pain

Oral Facial Pain

Treatment

Placebo

Rimegepant

Clinical Study ID

NCT05399485
BHV3000-309
C4951021
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 permonth within the last 3 months prior to the Screening Visit (month is defined as 4weeks 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 ifthe dose has been stable for at least 3 months (12 weeks) prior to the ObservationPeriod, 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 theymeet all other study entry criteria.

Exclusion

Exclusion Criteria:

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

  2. Subjects with headaches occurring 19 or more days per month (migraine ornon-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 recentlydiagnosed cardiovascular disease, such as ischemic heart disease, coronary arteryvasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), AcuteCoronary 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 beincluded who have stable hypertension and/or diabetes for 3 months prior toscreening).

  7. Subject with other pain syndromes, psychiatric conditions, dementia, or significantneurological 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 GastricBypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease thatcauses 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 suspectedinfection, hepatitis B or C, or cancer) that, in the investigator's opinion, wouldexpose them to undue risk of a significant adverse event (AE) or interfere withassessments 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 12months or subjects who have met DSM-V criteria for any significant substance usedisorder within the past 12 months from the date of the screening visit.

  11. Participation in any other investigational clinical trial while participating inthis clinical trial.

Study Design

Total Participants: 496
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 09, 2022
Estimated Completion Date:
November 07, 2024

Connect with a study center

  • Medical Corporation Seikokai Takanoko Hospital

    Matsuyama-shi, Ehime 790-0925
    Japan

    Site Not Available

  • Medical Corporation Seikokai Takanoko Hospital

    Matsuyama 1926099, Ehime 1864226 790-0925
    Japan

    Site Not Available

  • Ikeda Neurosurgical Clinic

    Kasuga-shi, Fukuoka 1863958 816-0824
    Japan

    Site Not Available

  • Jinnouchi Neurosurgical Clinic

    Kasuga-shi, Fukuoka 1863958 816-0802
    Japan

    Site Not Available

  • SUBARU Health Insurance Society Ota Memorial Hospital

    Ota-shi, Gunma 1863501 373-8585
    Japan

    Site Not Available

  • DOI CLINIC Internal Medicine/Neurology

    Hiroshima-shi, Hiroshima 730-0031
    Japan

    Site Not Available

  • Doi Clinic Internal Medicine/Neurology

    Hiroshima-shi, Hiroshima 730-0031
    Japan

    Active - Recruiting

  • Doi Clinic Internal Medicine/Neurology

    Hiroshima 1862415, Hiroshima 1862413 730-0031
    Japan

    Site Not Available

  • Nakamura Memorial Hospital

    Chuo-ku, Hokkaido 060-8570
    Japan

    Site Not Available

  • Nakamura Memorial Hospital

    Chuo-ku, Sapporo-shi, Hokkaido 060-8570
    Japan

    Site Not Available

  • Nakamura Memorial Hospital

    Sapporo shi, Hokkaido 060-8570
    Japan

    Site Not Available

  • Higashi Sapporo Neurology and Neurosurgery Clinic

    Sapporo-shi, Hokkaido 003-0003
    Japan

    Site Not Available

  • Higashi Sapporo Neuro. CL

    Shiroishi, Sapporo, Hokkaido 003-0003
    Japan

    Site Not Available

  • Japanese Red Cross Asahikawa Hospital

    Asahikawa-shi, Hokkaido 2130037 070-8530
    Japan

    Site Not Available

  • Nakamura Memorial Hospital

    Chūōku 11828195, Hokkaido 2130037 060-8570
    Japan

    Site Not Available

  • Higashi Sapporo Neurology and Neurosurgery Clinic

    Sapporo 2128295, Hokkaido 2130037 003-0003
    Japan

    Site Not Available

  • Konan Medical Center

    Kobe shi, Hyogo 658-0064
    Japan

    Site Not Available

  • Konan Medical Center

    Higashinada-ku, Kobe, Hyōgo 658-0064
    Japan

    Site Not Available

  • Konan Medical Center

    Higashinada-ku, Hyōgo 1862047 658-0064
    Japan

    Site Not Available

  • Nishinomiya Munic. Ctr. Hosp.

    Nishinomiya-shi, Hyōgo 1862047 663-8014
    Japan

    Site Not Available

  • Mito Kyodo General Hospital

    Mito-shi, Ibaraki 310-0015
    Japan

    Site Not Available

  • Mito Kyodo General Hospital

    Mito 2111901, Ibaraki 2112669 310-0015
    Japan

    Site Not Available

  • Kijima Neurosurgery Clinic

    Kahoku-gun, Ishikawa-ken 1861387 929-0342
    Japan

    Site Not Available

  • Iwate Medical University Uchimaru Medical Center

    Morioka-shi, Iwate 020-8505
    Japan

    Site Not Available

  • Iwate Medical University Uchimaru Medical Center

    Morioka 2111834, Iwate 2112518 020-8505
    Japan

    Site Not Available

  • Atsuchi Neurosurgery Hospital

    Kagoshima-shi, Kagoshima 892-0842
    Japan

    Site Not Available

  • Tanaka Neurosurgical Clinic

    Kagoshima-shi, Kagoshima 892-0844
    Japan

    Active - Recruiting

  • Tanaka neurosurgical clinic

    Kagoshima-shi, Kagoshima 892-0844
    Japan

    Site Not Available

  • Atsuchi Neurosurgery Hospital

    Kagoshima 1860827, Kagoshima-ken 1860825 892-0842
    Japan

    Site Not Available

  • Tanaka Neurosurgical Clinic

    Kagoshima 1860827, Kagoshima-ken 1860825 892-0844
    Japan

    Site Not Available

  • Fujitsu Clinic

    Nakahara, Kanagawa 211-8588
    Japan

    Site Not Available

  • Fujitsu Clinic

    Nakahara, Kawasaki, Kanagawa 211-8588
    Japan

    Site Not Available

  • St. Marianna Univ. Hospital

    Kawasaki-shi, Kanagawa 1860291 216-8511
    Japan

    Site Not Available

  • Fujitsu Clinic

    Nakahara 10419977, Kanagawa 1860291 211-8588
    Japan

    Site Not Available

  • Atago Hospital

    Kochi 1859146, Kochi 1859133 780-0051
    Japan

    Site Not Available

  • Umenotsuji Clinic

    Kochi 1859146, Kochi 1859133 780-8011
    Japan

    Site Not Available

  • Saiseikai Kumamoto Hospital

    Kumamoto-shi, Kumamoto 861- 4193
    Japan

    Site Not Available

  • Saisekai Kumamot Hospital

    Kumamoto-shi, Kumamoto 861-4193
    Japan

    Site Not Available

  • Saiseikai Kumamoto Hospital

    Kumamoto 1858421, Kumamoto 1858419 861- 4193
    Japan

    Site Not Available

  • Tatsuoka Neurology Clinic

    Kyoto-shi, Kyoto 600-8811
    Japan

    Site Not Available

  • Tatsuoka Neurology Clinic

    Kyoto 1857910, Kyoto 1857907 600-8811
    Japan

    Site Not Available

  • Atago Hospital

    Kochi-shi, Kōchi 780-0051
    Japan

    Site Not Available

  • Umenotsuji Clinic

    Kochi-shi, Kōchi 780-8011
    Japan

    Site Not Available

  • Sendai Headache and Neurology Clinic, Medical Corporation

    Sendai-shi, Miyagi 982-0014
    Japan

    Site Not Available

  • Sendai Headache and Neurology Clinic, Medical Corporation

    Sendai 2111149, Miyagi 2111888 982-0014
    Japan

    Site Not Available

  • Medical corporation oblige Ooba Clinic for Neurosurgery & Headache

    Oita-shi, Oita 870-0831
    Japan

    Site Not Available

  • Ooba Clinic for Neurosurgery & Headache

    Oita-shi, Oita 870-0831
    Japan

    Site Not Available

  • Ooba Clinic for Neurosurgery & Headache

    Ōita 1854487, Oita Prefecture 1854484 870-0831
    Japan

    Site Not Available

  • Makabe Clinic

    Okayama-shi, Okayama 700-0964
    Japan

    Site Not Available

  • Okayama City General Medical Center Okayama City Hospital

    Okayama-shi, Okayama 700-8557
    Japan

    Site Not Available

  • Makabe Clinic

    Okayama 1854383, Okayama-ken 1854381 700-0964
    Japan

    Site Not Available

  • Okayama City General Medical Center Okayama City Hospital

    Okayama 1854383, Okayama-ken 1854381 700-8557
    Japan

    Site Not Available

  • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

    Osaka-city, Osaka 530-8480
    Japan

    Site Not Available

  • Kitano Hospital Tazuke Kofukai

    Osaka-shi, Osaka 530-8480
    Japan

    Site Not Available

  • Kitano Hospital,Tazuke Kofukai Medical Research Institute

    Osaka-shi, Osaka 530-8480
    Japan

    Site Not Available

  • Tominaga Clinic

    Osaka-shi, Osaka 556-0015
    Japan

    Site Not Available

  • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

    Osaka 1853909, Osaka 1853904 530-8480
    Japan

    Site Not Available

  • Tominaga Clinic

    Osaka 1853909, Osaka 1853904 556-0015
    Japan

    Site Not Available

  • Kindai University Hospital

    Osakasayama-shi, Osaka 1853904 589-8511
    Japan

    Site Not Available

  • Takase Intern. Med. Clinic

    Toyonaka-shi, Osaka 1853904 560-0012
    Japan

    Site Not Available

  • Saitama Medical University Hospital

    Iruma-gun, Saitama 1853226 350-0495
    Japan

    Site Not Available

  • Saitama Neuropsychiatric Institute

    Saitama-shi, Saitama 1853226 338-8577
    Japan

    Site Not Available

  • JRC Shizuoka Hospital

    Shizuoka-shi, Shizuoka 420-0853
    Japan

    Site Not Available

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka-shi, Shizuoka 420-0853
    Japan

    Site Not Available

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka 1851717, Shizuoka 1851715 420-0853
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital

    Shimosuga, Tochigi 321-0293
    Japan

    Site Not Available

  • Dokkyo Medical Univ. Hosp.

    Shimotsuga-gun, Tochigi 1850310 321-0293
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyō-Ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 1850144 113-8431
    Japan

    Site Not Available

  • Tokai univ. hachioji hosp.

    Hachioji-shi, Tokyo 1850144 192-0032
    Japan

    Site Not Available

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo 1850144 108-8642
    Japan

    Site Not Available

  • Shinagawa Strings Clinic

    Minato-ku, Tokyo 1850144 108-0075
    Japan

    Site Not Available

  • USUDA CLINIC for internal medicine

    Setagaya-ku, Tokyo 1850144 156-0043
    Japan

    Site Not Available

  • Fukuuchi Pain Clinic

    Shinjuku-ku, Tokyo 1850144 160-0017
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-ku, Tokyo 1850144 160-8582
    Japan

    Site Not Available

  • Nishiogi Pain Clinic

    Suginami-ku, Tokyo 1850144 167-0054
    Japan

    Site Not Available

  • Sakura Clinic

    Toyama-shi, Toyama 930-0803
    Japan

    Site Not Available

  • Sakura Neuro Clinic

    Toyama-shi, Toyama 930-0803
    Japan

    Site Not Available

  • Sakura Neuro Clinic

    Toyama 1849876, Toyama 1849872 930-0803
    Japan

    Site Not Available

  • Nagamitsu Clinic

    Hofu-shi, Yamaguchi 1848681 747-0802
    Japan

    Site Not Available

  • Nagaseki Headache Clinic

    Kai-shi, Yamanashi 1848649 400-0124
    Japan

    Site Not Available

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