Safety and Efficacy Study in Adult Subjects With Acute Migraines
NCT ID: NCT03235479
Last Updated: 2023-02-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1485 participants
INTERVENTIONAL
2017-07-18
2018-01-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy in Adult Subjects With Acute Migraines
NCT03237845
Trial in Adult Subjects With Acute Migraines
NCT03461757
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
Open Label Safety Study in Acute Treatment of Migraine
NCT03266588
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rimegepant 75 mg
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.
Rimegepant
75 mg tablet QD
Placebo
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.
Placebo
Placebo tablet to match rimegepant dose QD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rimegepant
75 mg tablet QD
Placebo
Placebo tablet to match rimegepant dose QD
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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 mal-absorption
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, 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central Research Associates, Inc
Birmingham, Alabama, United States
Neurological Physicians of Arizona/Radiant Research Inc
Gilbert, Arizona, United States
Clinical Research Consortium Arizona
Tempe, Arizona, United States
Radiant Research, Inc.
Tucson, Arizona, United States
Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Pharmacology Research Institute
Encino, California, United States
Optimus Medical Group
San Francisco, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
Diablo Clinical Research, Inc
Walnut Creek, California, United States
Qps Mra, Llc
Hollywood, Florida, United States
Multi-Specialty Research Associates, Inc
Lake City, Florida, United States
Qps Mra, Llc
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Ormond Medical Arts Pharmaceutical Research
Ormond Beach, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
Boston Clinical Trials, Inc
Boston, Massachusetts, United States
Milford Emergency Associates, Inc.
Marlborough, Massachusetts, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc
Minneapolis, Minnesota, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Meridian Clinical Research -Norfolk
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Clinical Research Consortium- Las Vegas
Las Vegas, Nevada, United States
Hassman Research Institute, LLC
Berlin, New Jersey, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Central New York Clinical Research
Manlius, New York, United States
Fieve Clinical Research
New York, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
PharmQuest, LLC
Greensboro, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Oregon Center for Clinical Investigations, Inc
Portland, Oregon, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, United States
FutureSearch Trials of Neurology, LP
Austin, Texas, United States
FutureSearch Trials of Neurology, LP
Dallas, Texas, United States
Texas Center for Drug Development
Houston, Texas, United States
J.Lewis Research Inc / Foothill Family Clinic South
Salt Lake City, Utah, United States
J.Lewis Research Inc. / Jordan River Family Med
South Jordan, Utah, United States
Clinical Research Associates of Tidewater, Inc.
Norfolk, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BHV-3000-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.