Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults
NCT ID: NCT03732638
Last Updated: 2024-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
1590 participants
INTERVENTIONAL
2018-11-14
2021-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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DBT Rimegepant/OL Rimegepant
DBT Phase (Weeks 1 through 12): Participants received a single oral dose of rimegepant 75 mg tablet every other day (EOD) for 12 weeks.
OLE Phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (as needed \[PRN\] dosing).
After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
Rimegepant
Rimegepant 75 mg tablet EOD
DBT Placebo/OL Rimegepant
DBT Phase (Weeks 1 through 12): Participants received a single oral dose of placebo matching to rimegepant tablet EOD for 12 weeks.
OLE Phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing).
After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
Rimegepant
Rimegepant 75 mg tablet EOD
Placebo
Placebo tablet to match rimegepant tablet EOD
Interventions
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Rimegepant
Rimegepant 75 mg tablet EOD
Placebo
Placebo tablet to match rimegepant tablet EOD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4 - 72 hours if untreated
3. Per subject report, 4 - 18 migraine attacks of moderate to severe intensity per month within the last 3 months prior to the Screening Visit
4. 6 or more migraine days during the Observation Period
5. Not more than 18 headache days during the Observation Period
6. Ability to distinguish migraine attacks from tension/cluster headaches
7. 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.
Exclusion Criteria
3. 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
4. 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).
5. 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.
6. 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
7. 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
8. Body mass index ≥ 33 kg/m2
9. Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
10. History of gallstones or cholecystectomy.
11. 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Locations
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MDFirst Research-Chandler
Chandler, Arizona, United States
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
Premiere Research Institute
West Palm Beach, Florida, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
Northwest Clinical Trials, Inc
Boise, Idaho, United States
R&R Clinical Research
Idaho Falls, Idaho, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Family Medicine Specialists/CIS
Wauconda, Illinois, United States
Community Clinical Research Center
Anderson, Indiana, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Phoenix Medical Research
Prairie Village, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Crescent City Headache and Neurology Center
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
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States
Regeneris Medical
North Attleboro, Massachusetts, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Michigan Pain Consultants
Grand Rapids, Michigan, United States
MedPharmics, LLC
Biloxi, Mississippi, United States
Clinical Research Professionals, Inc.
Chesterfield, Missouri, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
The Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States
Clinvest Research LLC
Springfield, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Quality Clinical Research, Inc
Omaha, Nebraska, United States
Nevada Headache Institute
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States
Central New York Clinical Research
Manlius, New York, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States
Island Neurological, A Division of Prohealth Care Associates, LLP
Plainview, New York, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States
PharmQuest, LLC
Greensboro, North Carolina, United States
PMG Research
Raleigh, North Carolina, United States
Carolina Research Institute Center, Inc.
Shelby, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Hometown Urgent Care
Cincinnati, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Neurology Diagnostics Research
Dayton, Ohio, United States
Aventiv Research, Inc
Dublin, Ohio, United States
Oklahoma Headache Center
Norman, Oklahoma, United States
Tekton Research
Yukon, Oklahoma, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
BTC of Lincoln, LLC
Lincoln, Rhode Island, United States
OnSite Clinical Solutions
Dillon, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Tekton Research
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
North Texas Institute of Neurology & Headache
Frisco, Texas, United States
Victorium Clinical Research
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Red Star Research, LLC
Lake Jackson, Texas, United States
FMC Science
Lampasas, Texas, United States
Victorium Clinical Research
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
MedStar Georgetown Headache - Georgetown University
McLean, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Seattle Women's
Seattle, Washington, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
Countries
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References
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Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. 2025 Jun 30. doi: 10.1111/head.15002. Online ahead of print.
Mahon R, Tiwari S, Koch M, Ferraris M, Betts KA, Wang Y, Gao S, Proot P. Comparative effectiveness of erenumab versus rimegepant for migraine prevention using matching-adjusted indirect comparison. J Comp Eff Res. 2024 Mar;13(3):e230122. doi: 10.57264/cer-2023-0122. Epub 2024 Jan 4.
Powell LC, L'Italien G, Popoff E, Johnston K, O'Sullivan F, Harris L, Croop R, Coric V, Lipton RB. Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305). Adv Ther. 2023 Feb;40(2):585-600. doi: 10.1007/s12325-022-02369-x. Epub 2022 Nov 22.
Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Jan 2;397(10268):51-60. doi: 10.1016/S0140-6736(20)32544-7. Epub 2020 Dec 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BHV3000-305
Identifier Type: -
Identifier Source: org_study_id
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