Safety and Efficacy Study in Adult Subjects With Acute Migraines

NCT03235479 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BHV-3000-301
• Study Type: interventional
• Target: 1,485
• Locations: 1 country
• Sites: 50

Brief Summary

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

Conditions

Migraine, With or Without Aura

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Freedom From Pain at 2 Hours Post-dose

  Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.

  2 hours post-dose

• Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose

  MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.

  2 hours post-dose

Secondary Outcomes (11)

• Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose

  2 hours post-dose

• Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose

  2 hours post-dose

• Percentage of Participants With Pain Relief at 2 Hours Post-dose

  2 hours post-dose

• Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose

  2 hours post-dose

• Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose

  24 hours post-dose

Study Arms (2)

Rimegepant 75 mg

EXPERIMENTAL

Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

Drug: Rimegepant

Placebo

PLACEBO COMPARATOR

Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

Drug: Placebo

Interventions

Rimegepant DRUG

75 mg tablet QD

Also known as: BHV-3000

Rimegepant 75 mg

Placebo DRUG

Placebo tablet to match rimegepant dose QD

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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.
• Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

You may not qualify if:

• Patient history of HIV disease
• 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.
• 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)
• 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
• Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption
• 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, 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
• 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 the past 12 months from the date of the screening visit.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (50)

Central Research Associates, Inc

Birmingham, Alabama, 35205, United States

Location

Neurological Physicians of Arizona/Radiant Research Inc

Gilbert, Arizona, 85282, United States

Location

Clinical Research Consortium Arizona

Tempe, Arizona, 85283, United States

Location

Radiant Research, Inc.

Tucson, Arizona, 85712, United States

Location

Woodland International Research Group, LLC

Little Rock, Arkansas, 72211, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Optimus Medical Group

San Francisco, California, 94102, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Diablo Clinical Research, Inc

Walnut Creek, California, 94598, United States

Location

Qps Mra, Llc

Hollywood, Florida, 33024, United States

Location

Multi-Specialty Research Associates, Inc

Lake City, Florida, 32055, United States

Location

Qps Mra, Llc

Miami, Florida, 33143, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Ormond Medical Arts Pharmaceutical Research

Ormond Beach, Florida, 32174, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

New Orleans Center for Clinical Research

New Orleans, Louisiana, 70119, United States

Location

Boston Clinical Trials, Inc

Boston, Massachusetts, 02131, United States

Location

Milford Emergency Associates, Inc.

Marlborough, Massachusetts, 01752, United States

Location

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Clinical Research Institute, Inc

Minneapolis, Minnesota, 55402, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research -Norfolk

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Clinical Research Consortium- Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Hassman Research Institute, LLC

Berlin, New Jersey, 08009, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Central New York Clinical Research

Manlius, New York, 13104, United States

Location

Fieve Clinical Research

New York, New York, 10168, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

PharmQuest, LLC

Greensboro, North Carolina, 27408, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45227, United States

Location

Oregon Center for Clinical Investigations, Inc

Portland, Oregon, 97214, United States

Location

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, 19114-1029, United States

Location

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Meridian Clinical Research

Dakota Dunes, South Dakota, 57409, United States

Location

FutureSearch Trials of Neurology, LP

Austin, Texas, 78731, United States

Location

FutureSearch Trials of Neurology, LP

Dallas, Texas, 75231, United States

Location

Texas Center for Drug Development

Houston, Texas, 77081, United States

Location

J.Lewis Research Inc / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

J.Lewis Research Inc. / Jordan River Family Med

South Jordan, Utah, 84095, United States

Location

Clinical Research Associates of Tidewater, Inc.

Norfolk, Virginia, 23507, United States

Location

Tidewater Integrated Medical Research

Virginia Beach, Virginia, 23454, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Seattle Women's:Health, Research & Gynecology

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• Lipton RB, Thiry A, Morris BA, Croop R. Efficacy and Safety of Rimegepant 75 mg Oral Tablet, a CGRP Receptor Antagonist, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain Res. 2024 Jul 22;17:2431-2441. doi: 10.2147/JPR.S453806. eCollection 2024.

  PMID: 39070853 DERIVED

• Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686.

  PMID: 36739511 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Biohaven Pharmaceuticals, Inc.

clinicaltrials@biohavenpharma.com

203-404-0410

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind to Sponsor, Investigator and Participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: August 1, 2017
• Study Start: July 18, 2017
• Primary Completion: January 21, 2018
• Study Completion: January 26, 2018
• Last Updated: February 16, 2023
• Results First Posted: December 23, 2020

Record last verified: 2023-02

Locations

US (50)