Trial in Adult Subjects With Acute Migraines

NCT03461757 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BHV3000-303
• Study Type: interventional
• Target: 1,811
• Locations: 1 country
• Sites: 69

Brief Summary

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) 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 (21)

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

  2 hours post-dose

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

  2 hours post-dose

• Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose

  From 2 hours up to 24 hours post-dose

• Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose

  From 2 hours up to 24 hours post-dose

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

  24 hours post-dose

Study Arms (2)

Arm 1: Rimegepant 75 mg

EXPERIMENTAL

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

Drug: Rimegepant

Arm 2: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Rimegepant DRUG

75 mg ODT QD

Also known as: BHV-3000

Arm 1: Rimegepant 75 mg

Placebo DRUG

Placebo ODT to match rimegepant dose QD

Arm 2: Placebo

Eligibility Criteria

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

You may qualify if:

• \. Subject 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:
• Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
• Migraine attacks, on average, lasting about 4-72 hours if untreated
• Not more than 8 attacks of moderate to severe intensity per month within the 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.
• Subjects 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 screening visit and the dose is not expected to change during the course of the study.
• Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

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 being enrolled)
• Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), 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
• The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., 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 subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
• Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.
• Participation in any other investigational clinical trial while participating in this clinical trial

Sponsors & Collaborators

• Pfizer: lead

Study Sites (69)

Coastal Clinical Research, LLC

Mobile, Alabama, 36608, United States

Location

Clinical Research Consortium, An AMR Company

Tempe, Arizona, 85283, United States

Location

Radiant Research, Inc.

Tucson, Arizona, 85712, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Woodland International Research Group, LLC

Little Rock, Arkansas, 72211, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Synergy San Diego

National City, California, 91950, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Optimus Medical Group

San Francisco, California, 94102, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

Multi-Specialty Research Associates, Inc.

Lake City, Florida, 32055, United States

Location

Qps Mra, Llc

Miami, Florida, 33143, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Ormond Medical Arts Pharmaceutical Research

Ormond Beach, Florida, 32174, United States

Location

Synexus

Atlanta, Georgia, 30328, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Meridian Clinical Research, LLC

Savannah, Georgia, 31406, United States

Location

Heartland Research Associates LLC

Augusta, Kansas, 67010, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Cresent City Headache and Neurology Center LLC

Chalmette, Louisiana, 70043, United States

Location

New Orleans Center for Clinical Research

New Orleans, Louisiana, 70119, United States

Location

DelRicht Research

New Orleans, Louisiana, 70124, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721, United States

Location

Community Clinical Research Network/Milford Emergency Associates, Inc

Marlborough, Massachusetts, 01752, United States

Location

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55042, United States

Location

Clinical Research Institute, Inc.

Plymouth, Minnesota, 55441, United States

Location

StudyMetrix Research, LLC

City of Saint Peters, Missouri, 63303, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

CNS Research Science, Inc.

Jamaica, New York, 11432, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

PharmQuest, LLC

Greensboro, North Carolina, 27408, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

Wilmington Health, PLLC

Wilmington, North Carolina, 28401, United States

Location

Radiant Research, Inc.

Columbus, Ohio, 43212, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Hometown Urgent Care and Research

Dayton, Ohio, 45424, United States

Location

Neurology Diagnostics, Inc.

Dayton, Ohio, 45459, United States

Location

Aventiv Research Inc

Dublin, Ohio, 43016, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Coastal Carolina Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Meridian Clinical Research

Dakota Dunes, South Dakota, 57049, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Clinical Research Institute, Inc.

Nashville, Tennessee, 37203, United States

Location

Nashville Neuroscience Group

Nashville, Tennessee, 37203, United States

Location

Tekton Research, Inc

Austin, Texas, 78745, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Red Star Research

Lake Jackson, Texas, 77566, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, 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

Clinical Investigation Specialists, Inc.

Kenosha, Wisconsin, 53144, United States

Location

Related Publications (3)

• 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

• Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.

  PMID: 36125279 DERIVED

• Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.

  PMID: 31311674 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: March 6, 2018
• First Posted: March 12, 2018
• Study Start: February 27, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 15, 2018
• Last Updated: February 16, 2023
• Results First Posted: March 27, 2020

Record last verified: 2022-12

Locations

US (69)