Completed

Rimegepant for Migraine Prevention in Japanese Patients

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Study Aim

This study aims to evaluate the effectiveness of Rimegepant in reducing the number of migraine days per month in Japanese patients by observing changes from weeks 9 to 12.

What is being tested

Rimegepant

+ Placebo

Drug
Who is being recruted

Brain Diseases+8

+ Central Nervous System Diseases

+ Headache

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorPfizer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 9, 2022

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a medication called rimegepant to see if it effectively prevents migraines in Japanese individuals. Migraines are intense headaches that can cause severe pain and other symptoms like nausea and sensitivity to light and sound. The study aims to determine if rimegepant can reduce the number of migraine days people experience each month, which could significantly improve the quality of life for those who suffer from frequent migraines. Exploring new treatments like this is important because migraines can be debilitating and finding effective prevention methods can help many people. Participants in this study will be randomly assigned to receive either rimegepant or a placebo, which is a substance with no active medication, to compare the effects. The medication is taken orally, and the study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo. The main focus is to measure the change in the number of migraine days each month during the trial period, specifically from weeks 9 to 12. This is done using an electronic diary where participants record their headache experiences and any medication taken for migraines. By monitoring these changes, the study aims to assess the potential benefits and safety of rimegepant for migraine prevention.

Official TitleA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects
NCT05399485
Principal SponsorPfizer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

496 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesHeadacheMigraine DisordersNervous System DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache DisordersHeadache Disorders, Primary

Criteria

1 inclusion criteria required to participate
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.
11 exclusion criteria prevent from participating
Subject has a history of migraine with brainstem aura (basilar migraine), hemiplegic migraine or retinal migraine.
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.
History of systemic use of analgesics (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on 6 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
Subject with a history of HIV disease.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12

Group II

Placebo
Randomization Phase: one matching placebo every other day until week 12

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 44 locations

Suspended

Tokai univ. hachioji hosp.

Hachioji-shi, JapanOpen Tokai univ. hachioji hosp. in Google Maps
Suspended

Shinagawa Strings Clinic

Minato-ku, Japan
Suspended

Kitasato University Kitasato Institute Hospital

Minato-ku, Japan
Suspended

USUDA CLINIC for internal medicine

Setagaya-ku, Japan
Completed44 Study Centers