Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1811 participants
INTERVENTIONAL
2018-02-27
2018-10-15
Brief Summary
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Safety and Efficacy in Adult Subjects With Acute Migraines
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An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine
NCT03934086
Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults
NCT03732638
Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
NCT04574362
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1: Rimegepant 75 mg
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.
Rimegepant
75 mg ODT QD
Arm 2: Placebo
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.
Placebo
Placebo ODT to match rimegepant dose QD
Interventions
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Rimegepant
75 mg ODT QD
Placebo
Placebo ODT to match rimegepant dose QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
2. Migraine attacks, on average, lasting about 4-72 hours if untreated
3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
4. 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
5. 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.
6. 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.
7. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion Criteria
2. 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
3. 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)
4. 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.
5. 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
6. 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.
7. 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.
8. Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.
9. Participation in any other investigational clinical trial while participating in this clinical trial
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Locations
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Coastal Clinical Research, LLC
Mobile, Alabama, United States
Clinical Research Consortium, An AMR Company
Tempe, Arizona, United States
Radiant Research, Inc.
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Pharmacology Research Institute
Encino, California, 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
Synergy San Diego
National City, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Optimus Medical Group
San Francisco, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Yale University
New Haven, Connecticut, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
MD Clinical
Hallandale, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Qps Mra, Llc
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Ormond Medical Arts Pharmaceutical Research
Ormond Beach, Florida, United States
Synexus
Atlanta, Georgia, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Heartland Research Associates LLC
Augusta, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Cresent City Headache and Neurology Center LLC
Chalmette, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
NECCR Primacare Research, LLC
Fall River, Massachusetts, United States
Community Clinical Research Network/Milford Emergency Associates, Inc
Marlborough, Massachusetts, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Hassman Research Institute
Berlin, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
CNS Research Science, Inc.
Jamaica, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
PharmQuest, LLC
Greensboro, North Carolina, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
Radiant Research, Inc.
Columbus, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
Aventiv Research Inc
Dublin, Ohio, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Clinical Research Institute, Inc.
Nashville, Tennessee, United States
Nashville Neuroscience Group
Nashville, Tennessee, United States
Tekton Research, Inc
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Red Star Research
Lake Jackson, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BHV3000-303
Identifier Type: -
Identifier Source: org_study_id
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