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

Last updated: March 4, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Headaches

Pain (Pediatric)

Oral Facial Pain

Treatment

Placebo

Rimegepant 75 MG

Rimegepant 25 MG

Clinical Study ID

NCT05399459
BHV3000-313
C4951022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 50years 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 3months.

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

  5. Consistent migraine headaches of at least 2 migraine headache attacks of moderate orsevere intensity in each of the 3 months prior to Screening Visit and maintains thisrequirement 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 theScreening Period.

  7. Subjects on prophylactic migraine medication are permitted to remain on therapy ifthe dose has been stable for at least 3 months prior to the Screening Visit, and ifthe 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. History of use of analgesics (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] oracetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to theScreening Visit.

  3. 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.

  4. Uncontrolled hypertension or uncontrolled diabetes (however subjects can be includedwho have stable hypertension and/or diabetes for at least 3 months prior toscreening).

  5. Subject with other pain syndromes, psychiatric conditions, dementia, or significantneurological 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 GastricBypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a diseasethat 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 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.

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

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

Study Design

Total Participants: 897
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 09, 2022
Estimated Completion Date:
January 19, 2024

Connect with a study center

  • Tdc Ichikawa General Hospital

    Ichikawa-shi, Chiba 272-8513
    Japan

    Site Not Available

  • Tokyo Dental College Ichikawa General Hospital

    Ichikawa-shi, Chiba 272-8513
    Japan

    Site Not Available

  • Medical Corporation Seikokai Takanoko Hospital

    Matsuyama-shi, Ehime 790-0925
    Japan

    Site Not Available

  • Ikeda Neurosurgical Clinic

    Kasuga-shi, Fukuoka 816-0824
    Japan

    Site Not Available

  • Jinnouchi Neurosurgical Clinic

    Kasuga-shi, Fukuoka 816-0802
    Japan

    Site Not Available

  • Ota Memorial Hospital

    Ota-shi, Gunma 373-8585
    Japan

    Site Not Available

  • SUBARU Health Insurance Society Ota Memorial Hospital

    Ota-shi, Gunma 373-8585
    Japan

    Site Not Available

  • DOI CL Intern. Med./Neurol.

    Hiroshima-shi, Hiroshima 730-0031
    Japan

    Site Not Available

  • DOI CLINIC Internal Medicine/Neurology

    Hiroshima-shi, Hiroshima 730-0031
    Japan

    Site Not Available

  • Japanese Red Cross Asahikawa Hospital

    Asahikawa-shi, Hokkaido 070-8530
    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

  • Nakamura Memorial Hospital

    Sapporo-shi, Hokkaido 060-8570
    Japan

    Site Not Available

  • Konan Medical Center

    Kobe shi, Hyogo 658-0064
    Japan

    Site Not Available

  • Nishinomiya Municipal Central Hospital

    Nishinomiya-shi, Hyogo 663-8014
    Japan

    Site Not Available

  • Konan Medical Center

    Kobe-shi, Hyōgo 658-0064
    Japan

    Site Not Available

  • Mito Kyodo General Hospital

    Mito-shi, Ibaraki 310-0015
    Japan

    Site Not Available

  • Kijima Neurosurgery Clinic

    Kahoku-gun, Ishikawa 929-0342
    Japan

    Site Not Available

  • Iwate Med. Univ. Uchimaru MC

    Morioka-shi, Iwate 020-8505
    Japan

    Site Not Available

  • Iwate Medical University Uchimaru Medical Center

    Morioka-shi, Iwate 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

    Site Not Available

  • Tanaka neurosurgical clinic

    Kagoshima-shi, Kagoshima 892-0844
    Japan

    Active - Recruiting

  • Fujitsu Clinic

    Kawasaki-shi, Kanagawa 211-8588
    Japan

    Site Not Available

  • St. Marianna Univ. Hospital

    Kawasaki-shi, Kanagawa 216-8511
    Japan

    Site Not Available

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa 216-8511
    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

  • Saiseikai Kumamoto Hospital

    Kumamoto-shi, Kumamoto 861- 4193
    Japan

    Site Not Available

  • Saisekai Kumamot Hospital

    Kumamoto-shi, Kumamoto 861-4193
    Japan

    Site Not Available

  • Kyoto Okamoto Memorial Hospital

    Kumiyama-cho, Kyoto 613-0034
    Japan

    Site Not Available

  • Kyoto Okamoto Memorial Hospital

    Kumiyama-cho, Kuse-gun, Kyoto 613-0034
    Japan

    Site Not Available

  • Tatsuoka Neurology Clinic

    Kyoto-shi, Kyoto 600-8811
    Japan

    Site Not Available

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto-shi, Kyoto 602-8566
    Japan

    Site Not Available

  • Ishikawa Clinic

    Sakyo-ku, Kyoto 606-0851
    Japan

    Site Not Available

  • Ishikawa Clinic

    Sakyo-ku, Kyoto-city, Kyoto 606-0851
    Japan

    Site Not Available

  • Tatsuoka Neurology Clinic

    Shimogyo-ku, Kyoto 600-8811
    Japan

    Site Not Available

  • Tatsuoka Neurology Clinic

    Shimogyo-ku, Kyoto, Kyoto 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

  • Narikawa Neurological Clinic

    Izumi-ku, Miyagi 981-3126
    Japan

    Site Not Available

  • Narikawa Neurological Clinic

    Izumi-ku, Sendai-city, Miyagi 981-3126
    Japan

    Site Not Available

  • Sendai Headache and Neurology Clinic, Medical Corporation

    Sendai-shi, Miyagi 982-0014
    Japan

    Site Not Available

  • Medical corporation oblige Ooba Clinic for Neurosurgery & Headache

    Oita-shi, Oita 870-0831
    Japan

    Site Not Available

  • Ooba CL Neurosurg. & Headache

    Oita-shi, Oita 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

  • Tominaga Clinic

    Naniwa-ku, Osaka 556-0015
    Japan

    Site Not Available

  • Tominaga Clinic

    Naniwa-ku, Osaka-shi, Osaka 556-0015
    Japan

    Site Not Available

  • Kitano Hospital,Tazuke Kofukai Medical Research Institute

    Osaka-city, Osaka 530-8480
    Japan

    Active - Recruiting

  • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

    Osaka-city, 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

  • Kindai University Hospital

    Osakasayama-shi, Osaka 589-8511
    Japan

    Site Not Available

  • Takase Intern. Med. Clinic

    Toyonaka-shi, Osaka 560-0012
    Japan

    Site Not Available

  • Takase Internal Medicine Clinic

    Toyonaka-shi, Oska 560-0012
    Japan

    Site Not Available

  • Saitama Medical University Hospital

    Iruma-gun, Saitama 350-0495
    Japan

    Site Not Available

  • Saitama Neuropsychiatric Institute

    Saitama-shi, Saitama 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

  • Dokkyo Medical Univ. Hosp.

    Shimotsuga-gun, Tochigi 321-0293
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi 321-0293
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyō-Ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Tokai university hachioji hospital

    Hachioji-shi, Tokyo 192-0032
    Japan

    Site Not Available

  • Kitasato University Kitasato Institute Hospital

    Minato-Ku, Tokyo 108-8642
    Japan

    Active - Recruiting

  • Shinagawa Strings Clinic

    Minato-Ku, Tokyo 108-0075
    Japan

    Active - Recruiting

  • Kitasato Institute Hospital

    Minato-ku, Tokyo 108-8642
    Japan

    Site Not Available

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo 108-8642
    Japan

    Site Not Available

  • Shinagawa Strings Clinic

    Minato-ku, Tokyo 108-0075
    Japan

    Site Not Available

  • USUDA CLINIC for internal medicine

    Setagaya-Ku, Tokyo 156-0043
    Japan

    Active - Recruiting

  • USUDA CLINIC for internal medicine

    Setagaya-ku, Tokyo 156-0043
    Japan

    Site Not Available

  • Tokyo Headache Clinic

    Shibuya-Ku, Tokyo 151-0051
    Japan

    Site Not Available

  • Fukuuchi Pain Clinic

    Shinjuku-Ku, Tokyo 160-0017
    Japan

    Active - Recruiting

  • Keio University Hospital

    Shinjuku-Ku, Tokyo 160-8582
    Japan

    Active - Recruiting

  • Fukuuchi Pain Clinic

    Shinjuku-ku, Tokyo 160-0017
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-ku, Tokyo 160-8582
    Japan

    Site Not Available

  • Nishiogi Pain Clinic

    Suginami-Ku, Tokyo 167-0054
    Japan

    Active - Recruiting

  • Nishiogi Pain Clinic

    Suginami-ku, Tokyo 167-0054
    Japan

    Site Not Available

  • Suzuki Kei Yasuragi clinic

    Tachikawa-city, Tokyo 190-0001
    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

  • Nagamitsu Clinic

    Hofu-shi, Yamaguchi 747-0802
    Japan

    Site Not Available

  • Nagaseki Headache Clinic

    Kai-shi, Yamanashi 400-0124
    Japan

    Site Not Available

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