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Safety and Efficacy in Adult Subjects With Acute Migraines | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy in Adult Subjects With Acute Migraines

BHV3000-302 : Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

NCT03237845•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient 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, Beta version\[1\] including the following:
•* Not more than 8 attacks of moderate or severe intensity per month within last 3 months
•* 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
•2. 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
•3. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
•4. Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Exclusion Criteria

•1. Patient history of HIV disease
•2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients 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.
•3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
•4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
•5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption.
•6. The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitisB 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 ofthe trial
•7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within thepast 12 months from the date of the screening visit.

Locations (50)

Coastal Clinical Research

Mobile, Alabama, United States

Thunderbird Internal Medicine / Radiant Research, Inc.

Glendale, Arizona, United States

Woodland Research Northwest, LLC

Rogers, Arkansas, United States

eStudySite

La Mesa, California, United States

Collaborative Neuroscience Network, LLC

Long Beach, California, United States

Pharmacology Research Institute

Los Alamitos, California, United States

Pharmacology Research Institute

Newport Beach, California, United States

Pacific Research Partners LLC

Oakland, California, United States

National Research Institute

Panorama City, California, United States

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, United States

Key Dates

Start Date

July 27, 2017

Primary Completion Date

January 25, 2018

Completion Date

January 31, 2018

Last Updated

February 16, 2023

Enrollment

1,499

ACTUAL participants

Conditions

Migraine, With or Without Aura

Interventions

Rimegepant

DRUG

Placebo

DRUG

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

NCT02873221

Migraine, With or Without Aura

View study

COMPLETEDPHASE3

Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

NCT02867709

Migraine, With or Without Aura

View study

COMPLETEDPHASE2/PHASE3

Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

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 16, 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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