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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects

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

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Rimegepant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Japan
  • 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
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 730-0031
      • DOI CLINIC Internal Medicine/Neurology
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8530
      • Japanese Red Cross Asahikawa Hospital
    • Chuo-ku, Sapporo-shi, Hokkaido, Japan, 060-8570
      • Nakamura Memorial Hospital
    • Sapporo-shi, Hokkaido, Japan, 003-0003
      • Higashi Sapporo Neurology and Neurosurgery Clinic
    • Shiroishi, Sapporo, Hokkaido, Japan, 003-0003
      • Higashi Sapporo Neuro. CL
  • Hyōgo
    • Higashinada-ku, Kobe, Hyōgo, Japan, 658-0064
      • Konan Medical Center
    • Nishinomiya-shi, Hyōgo, Japan, 663-8014
      • Nishinomiya Munic. Ctr. Hosp.
  • 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
  • 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 Univ. Hospital
    • Nakahara, Kawasaki, Kanagawa, Japan, 211-8588
      • Fujitsu Clinic
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan, 861- 4193
      • Saiseikai Kumamoto Hospital
    • Kumamoto-shi, Kumamoto, Japan, 861-4193
      • Saisekai Kumamot Hospital
  • Kyoto
    • Kyoto-shi, 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
    • Sendai-shi, Miyagi, Japan, 982-0014
      • Sendai Headache and Neurology Clinic, Medical Corporation
  • Oita
    • Oita-shi, Oita, Japan, 870-0831
      • Ooba Clinic for Neurosurgery & 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
    • Osaka-city, Osaka, Japan, 530-8480
      • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
    • Osaka-shi, Osaka, Japan, 530-8480
      • Kitano Hospital 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
  • 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 Univ. Hosp.
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Hachioji-shi, Tokyo, Japan, 192-0032
      • Tokai univ. hachioji hosp.
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Minato-ku, Tokyo, Japan, 108-0075
      • Shinagawa Strings Clinic
    • Setagaya-ku, Tokyo, Japan, 156-0043
      • USUDA CLINIC for internal medicine
    • 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
  • 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 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) or hemiplegic 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 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 (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)
7. Subject has a current diagnosis of major depression, 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 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.
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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rimegepant; Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12	Drug: Rimegepant; Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12; Other Names: BHV3000
Placebo Comparator: Placebo; Randomization Phase: one matching placebo every other day until week 12	Drug: Placebo; Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction from baseline in the mean number of migraine days per month in the last four weeks (week 9 to 12) of the double-blind treatment (DBT) phase	Weeks 9 to 12 of DBT phase

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants that have least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month in the last 4 weeks of the double-blind treatment (DBT) phase	Weeks 9 to 12 of DBT phase
Reduction from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment (DBT) phase	Observation Period (OP) and Week 1 to 12 of DBT Phase
Frequency of use of acute migraine specific medication (i.e., triptans and ergotamines) in the last 4 weeks of the double-blind treatment phase	Weeks 9 to 12 of DBT Phase
Reduction from baseline in the mean number of migraine days per month in the first 4 weeks of the double-blind treatment phase	OP and Weeks 1 to 4 of DBT Phase
Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 role function - restrictive domain score at Week 12 of the double-blind treatment phase	Baseline, Week 12 of DBT Phase
Change from baseline in the Migraine Disability Assessment total score at Week 12 of the double-blind treatment phase	Baseline, Week 12 of DBT Phase
Change from baseline in the EQ-5D-5L score at Week 12 of the double blind treatment phase	Baseline, Week 12 of DBT Phase
Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to drug discontinuation	Through study completion, 52 weeks
Number of participants with clinical significant laboratory abnormalities	Through study completion, 52 weeks
Frequency of ALT or AST > 3x ULN with concurrent elevations in bilirubin >2x ULN in subjects treated with rimegepant	Through study completion, 52 weeks
Number of participants with hepatic-related adverse events (AEs) and the frequency of hepatic-related treatment discontinuations in subjects treated with rimegepant	Through study completion, 52 weeks

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 18, 2024
• Study Completion (Estimated): November 9, 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 (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Headache; Migraine Prevention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: BHV3000-309; C4951021 (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: No
• Studies a U.S. FDA-regulated device product: No