Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Key facts

Study ID

NCT03732638

Run by

Pfizer

People needed

1590

Starts

2018-11-14

Expected to finish

2021-02-02

Last updated by the study team

2024-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Age of onset of migraines prior to 50 years of age
• Migraine attacks, on average, lasting 4 - 72 hours if untreated
• Per subject report, 4 - 18 migraine attacks of moderate to severe intensity per month within the last 3 months prior to the Screening Visit
• 6 or more migraine days during the Observation Period
• Not more than 18 headache days during the Observation Period
• Ability to distinguish migraine attacks from tension/cluster headaches
• Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.

You may not qualify if…

• Subject with a history of HIV disease
• 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
• 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 screening).
• Subjects with major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening visit.
• Subjects with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
• 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
• Body mass index ≥ 33 kg/m2
• Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
• History of gallstones or cholecystectomy.
• 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.

Where it is running

• MedPharmics, LLC — Phoenix, Arizona, United States
• Tucson Neuroscience Research — Tucson, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Axiom Research, LLC — Apple Valley, California, United States
• Axiom Research, LLC — Colton, California, United States
• eStudySite — La Mesa, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Collaborative Neuroscience Network, LLC — Long Beach, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Optimus Medical Group — San Francisco, California, United States
• Artemis Institute for Clinical Research — San Marcos, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• California Neuroscience Research Medical Group — Sherman Oaks, California, United States
• Ki Health Partners, LLC, dba New England Institute for Clinical Research — Stamford, Connecticut, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Galiz Research — Hialeah, Florida, United States
• Multi-Specialty Research Associates, Inc. — Lake City, Florida, United States
• Qps Mra, Llc — Miami, Florida, United States
• AppleMed Research Group, LLC — Miami, Florida, United States
• Harmony Clinical Research — North Miami Beach, Florida, United States
• Ormond Medical Arts Pharmaceutical Research Center — Ormond Beach, Florida, United States
• JSV Clinical Research Study Inc. — Tampa, Florida, United States
• MDFirst Research-Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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