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Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine

NCT01430442•Pfizer

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.

Detailed Description

Intervention Model: Parallel Versus Comparator + Placebo

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient with at least 1-year history of migraines (with or without aura) including the following:
•* Migraine attacks more than 1 year with age of onset prior to 50 years of age
•* Migraine attacks, on average, last about 4 - 72 hours if untreated
•* No more than 8 attacks of moderate to severe intensity per month within last 3 months
•* Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
•* Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
•Male and female ≥ 18 years and ≤ age 65
•No clinically significant abnormality identified on the medical or laboratory evaluation

Exclusion Criteria

•Patient has a history of basilar migraine or hemiplegic migraine
•Patient does not receive migraine relief from triptan migraine treatment
•Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
•History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
•History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months

Locations (41)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Clinical Res. Advantage Inc/ Desert Clinical Research Llc

Tempe, Arizona, United States

University Of California, San Francisco

San Francisco, California, United States

California Medical Clinic For Headache

Santa Monica, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Radiant Research, Inc.

Denver, Colorado, United States

Miami Research Associates

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Compass Research, Llc

Orlando, Florida, United States

Key Dates

Start Date

October 1, 2011

Primary Completion Date

May 1, 2012

Completion Date

May 1, 2012

Last Updated

February 28, 2023

Enrollment

1,026

ACTUAL participants

Conditions

MigraineAcute Treatment of Migraine

Interventions

Rimegepant

DRUG

Placebo

DRUG

Sumatriptan

DRUG

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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RECRUITINGPHASE3

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

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

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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: February 28, 2023Data 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.

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Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

Inclusion Criteria

Exclusion Criteria

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

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