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Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05399459•Pfizer

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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 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), hemiplegic migraine or retinal 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 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.
•4. Uncontrolled hypertension or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
•5. Subject with other pain syndromes, psychiatric conditions, dementia, or significant neurological 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 Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that 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 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.
•8. History of alcohol abuse and/or illicit drug use meeting DSM-V criteria for substance use disorder within 6 months of screening.
•9. Participation in any other investigational clinical trial while participating in this clinical trial.

Locations (50)

Tokyo Dental College Ichikawa General Hospital

Ichikawa-shi, Chiba, Japan

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 CL Intern. Med./Neurol.

Hiroshima, Hiroshima, Japan

Japanese Red Cross Asahikawa Hospital

Asahikawa-shi, Hokkaido, Japan

Higashi Sapporo Neurology and Neurosurgery Clinic

Sapporo, Hokkaido, Japan

Nakamura Memorial Hospital

Sapporo, Hokkaido, Japan

Konan Medical Center

Kobe, Hyōgo, Japan

Key Dates

Start Date

August 9, 2022

Primary Completion Date

January 19, 2024

Completion Date

January 19, 2024

Last Updated

March 7, 2025

Enrollment

897

ACTUAL participants

Conditions

Migraine

Interventions

Rimegepant 25 MG

DRUG

Rimegepant 75 MG

DRUG

Placebo

DRUG

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713

Chronic Migraine

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RECRUITINGPHASE3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

NCT06641466

Menstrual Migraine

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.