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

Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Rimegepant 25 MG; Drug: Rimegepant 75 MG

• Study Type: Interventional
• Enrollment (Actual): 803
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Ichikawa-shi, Chiba, Japan, 272-8513
      • Tdc Ichikawa General Hospital
    • Ichikawa-shi, Chiba, Japan, 272-8513
      • Tokyo Dental College Ichikawa General Hospital
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 790-0925
      • Medical Corporation Seikokai Takanoko Hospital
  • Fukuoka
    • Kasuga-shi, Fukuoka, Japan, 816-0802
      • Jinnouchi Neurosurgical Clinic
    • Kasuga-shi, Fukuoka, Japan, 816-0824
      • Ikeda Neurosurgical Clinic
  • Gunma
    • Ota-shi, Gunma, Japan, 373-8585
      • SUBARU Health Insurance Society Ota Memorial Hospital
    • Ota-shi, Gunma, Japan, 373-8585
      • Ota Memorial Hospital
    • Ota-shi, Gunma, Japan, 375-8585
      • SUBARU Health Insurance Society Ota Memorial Hospital
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 730-0031
      • Doi Clinic Internal Medicine/Neurology
    • Hiroshima-shi, Hiroshima, Japan, 730-0031
      • DOI CL Intern. Med./Neurol.
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8530
      • Japanese Red Cross Asahikawa Hospital
    • Sapporo shi, Hokkaido, Japan, 060-8570
      • Nakamura Memorial Hospital
    • Sapporo-shi, Hokkaido, Japan, 003-0003
      • Higashi Sapporo Neurology and Neurosurgery Clinic
    • Sapporo-shi, Hokkaido, Japan, 060-8570
      • Nakamura Memorial Hospital
  • Hyogo
    • Kobe shi, Hyogo, Japan, 658-0064
      • Konan Medical Center
    • Nishinomiya-shi, Hyogo, Japan, 663-8014
      • Nishinomiya Municipal Central Hospital
  • Hyōgo
    • Kobe-shi, Hyōgo, Japan, 658-0064
      • Konan Medical Center
  • Ibaraki
    • Mito-shi, Ibaraki, Japan, 310-0015
      • Mito Kyodo General Hospital
  • Ishikawa
    • Kahoku-gun, Ishikawa, Japan, 929-0342
      • Kijima Neurosurgery Clinic
  • Iwate
    • Morioka-shi, Iwate, Japan, 020-8505
      • Iwate Medical University Uchimaru Medical Center
    • Morioka-shi, Iwate, Japan, 020-8505
      • Iwate Med. Univ. Uchimaru MC
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 892-0842
      • Atsuchi Neurosurgery Hospital
    • Kagoshima-shi, Kagoshima, Japan, 892-0844
      • Tanaka Neurosurgical Clinic
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St. Marianna Univ. Hospital
    • Kawasaki-shi, Kanagawa, Japan, 211-8588
      • Fujitsu Clinic
    • Nakahara, Kawasaki, Kanagawa, Japan, 211-8588
      • Fujitsu Clinic
  • Kochi
    • Kochi-shi, Kochi, Japan, 780-0051
      • Atago Hospital
    • Kochi-shi, Kochi, Japan, 780-8011
      • Umenotsuji Clinic
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan, 861-4193
      • Saiseikai Kumamoto Hospital
    • Kumamoto-shi, Kumamoto, Japan, 861- 4193
      • Saiseikai Kumamoto Hospital
    • Kumamoto-shi, Kumamoto, Japan, 861-4193
      • Saisekai Kumamot Hospital
  • Kyoto
    • Kumiyama-cho, Kuse-gun, Kyoto, Japan, 613-0034
      • Kyoto Okamoto Memorial Hospital
    • Kyoto-shi, Kyoto, Japan, 602-8566
      • University Hospital Kyoto Prefectural University of Medicine
    • Kyoto-shi, Kyoto, Japan, 600-8811
      • Tatsuoka Neurology Clinic
    • Sakyo-ku, Kyoto-city, Kyoto, Japan, 606-0851
      • Ishikawa Clinic
    • Shimogyo-ku, Kyoto, Kyoto, Japan, 600-8811
      • Tatsuoka Neurology Clinic
  • Kōchi
    • Kochi-shi, Kōchi, Japan, 780-0051
      • Atago Hospital
    • Kochi-shi, Kōchi, Japan, 780-8011
      • Umenotsuji Clinic
  • Miyagi
    • Izumi-ku, Sendai-city, Miyagi, Japan, 981-3126
      • Narikawa Neurological Clinic
    • Sendai-shi, Miyagi, Japan, 982-0014
      • Sendai Headache and Neurology Clinic, Medical Corporation
  • Oita
    • Oita-shi, Oita, Japan, 870-0831
      • Medical corporation oblige Ooba Clinic for Neurosurgery & Headache
    • Oita-shi, Oita, Japan, 870-0831
      • Ooba CL Neurosurg. & Headache
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8557
      • Okayama City General Medical Center Okayama City Hospital
    • Okayama-shi, Okayama, Japan, 700-0964
      • Makabe Clinic
  • Osaka
    • Naniwa-ku, Osaka-shi, Osaka, Japan, 556-0015
      • Tominaga Clinic
    • Osaka-city, Osaka, Japan, 530-8480
      • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
    • Osaka-shi, Osaka, Japan, 530-8480
      • Kitano Hospital,Tazuke Kofukai Medical Research Institute
    • Osaka-shi, Osaka, Japan, 556-0015
      • Tominaga Clinic
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital
    • Toyonaka-shi, Osaka, Japan, 560-0012
      • Takase Intern. Med. Clinic
  • Oska
    • Toyonaka-shi, Oska, Japan, 560-0012
      • Takase Internal Medicine Clinic
  • Saitama
    • Iruma-gun, Saitama, Japan, 350-0495
      • Saitama Medical University Hospital
    • Saitama-shi, Saitama, Japan, 338-8577
      • Saitama Neuropsychiatric Institute
  • Shizuoka
    • Shizuoka-shi, Shizuoka, Japan, 420-0853
      • Japanese Red Cross Shizuoka Hospital
    • Shizuoka-shi, Shizuoka, Japan, 420-0853
      • JRC Shizuoka Hospital
  • Tochigi
    • Shimotsuga-gun, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital
    • Shimotsuga-gun, Tochigi, Japan, 321-0293
      • Dokkyo Medical Univ. Hosp.
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Bunkyō-Ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Hachioji-shi, Tokyo, Japan, 192-0032
      • Tokai University Hachioji Hospital
    • Minato-Ku, Tokyo, Japan, 108-0075
      • Shinagawa Strings Clinic
    • Minato-Ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato Institute Hospital
    • Setagaya-Ku, Tokyo, Japan, 156-0043
      • USUDA CLINIC for internal medicine
    • Shibuya-Ku, Tokyo, Japan, 151-0051
      • Tokyo Headache Clinic
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 160-0017
      • Fukuuchi Pain Clinic
    • Suginami-Ku, Tokyo, Japan, 167-0054
      • Nishiogi Pain Clinic
    • Tachikawa-city, Tokyo, Japan, 190-0001
      • Suzuki Kei Yasuragi clinic
  • Toyama
    • Toyama-shi, Toyama, Japan, 930-0803
      • Sakura Clinic
    • Toyama-shi, Toyama, Japan, 930-0803
      • Sakura Neuro Clinic
  • Yamaguchi
    • Hofu-shi, Yamaguchi, Japan, 747-0802
      • Nagamitsu Clinic
  • Yamanashi
    • Kai-shi, Yamanashi, Japan, 400-0124
      • Nagaseki Headache Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 the 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 the 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) or hemiplegic 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 with a history of HIV disease
4. 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
5. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
6. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
7. 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
8. The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known 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.
9. 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.
10. Participation in any other investigational clinical trial while participating in this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rimegepant 25 mg; Single dose of 25 mg orally disintegrating tablet of rimegepant	Drug: Rimegepant 25 MG; Single dose of 25 mg orally disintegrating tablet of rimegepant; Other Names: BHV3000
Experimental: Rimegepant 75 mg; Single dose of 75 mg orally disintegrating tablet of rimegepant	Drug: Rimegepant 75 MG; Single dose of 75 mg orally disintegrating tablet of rimegepant; Other Names: BHV3000
Placebo Comparator: Placebo; Matching placebo tablet	Drug: Placebo; Matching placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain freedom at 2 hours post-dose	Measured by the number of subjects that report no pain. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).	2 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief at 2 hours post-dose.	Measured by the number of subjects that report a pain level of moderate or severe at baseline and then report a pain level of none or mild at two hours post-dose	Baseline, 2 hours post-dose
Freedom from the Most Bothersome Symptom (MBS) associated with migraine at 2 hours post-dose.	Measured by the number of subjects that report the absence of their MBS at 2 hours post-dose. The MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present)	2 hours post-dose
Ability to function normally at 2 hours post-dose	Measured by the number of subjects that self-report as "normal" on the Functional Disability scale. The Functional Disability scale is a four-point scale: normal, mildly impaired, severely impaired, requires bedrest.	2 hours post-dose
Sustained pain relief from 2 to 24 hours post-dose	Measured by the number of subjects that do not use any rescue medications, and do not experience any moderate or severe headache pain through the time period of interest.	From 2 hours up to 24 hours post-dose
Frequency of use of rescue medication within 24 hours of initial treatment.	Measured by the number of subjects that take rescue medication within 24 after administration of study medication	24 hours post-dose
Sustained pain relief from 2 to 48 hours post-dose	Measured by the number of subjects that do not use any rescue medications, and do not experience any moderate or severe headache pain through the time period of interest.	From 2 hours up to 48 hours post-dose
Freedom from photophobia at 2 hours post-dose	Measured by tabulating the number of subjects that report the absence of photophobia at 2 hours post-dose in the subset of subjects that reported the presence of photophobia at headache baseline	Baseline, 2 hours post-dose
Sustained pain freedom from 2 to 24 hours post-dose	Measured by the number of subjects that do not use any rescue medications, and do not experience any headache pain through the time period of interest	From 2 hours up to 24 hours post-dose
Freedom from phonophobia at 2 hours post-dose	Measured by tabulating the number of subjects that report the absence of phonophobia at 2 hours post-dose in the subset of subjects that reported the presence of phonophobia at headache baseline	Baseline, 2 hours post-dose
Sustained pain freedom from 2 to 48 hours post-dose.	Measured by the number of subjects that do not use any rescue medications, and do not experience any headache pain through the time period of interest.	From 2 hours up to 48 hours post-dose
Freedom from nausea at 2 hours post-dose	Measured by tabulating the number of subjects that report the absence of nausea at 2 hours post-dose in the subset of subjects that reported the presence of nausea at headache baseline	Baseline, 2 hours post-dose
Incidence of pain relapse from 2 to 48 hours post-dose	Measured by the number of subjects that are pain free at 2 hours post-dose and then have a headache of any severity (response of 1, 2 or 3 on the 4 point scale) within 48 hours after administration of study medication	From 2 hours up to 48 hours post-dose

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): January 19, 2024
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Headache; Acute Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: BHV3000-313; C4951022 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes