Clinical trial NCT03732638: Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults
Official title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Migraine
Keywords: Migraine
Prevention
Prophylaxis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-11-06
Enrollment: 1590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.


Eligibility criteria: Inclusion Criteria:

1. Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

   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:
2. Subject with a history of HIV disease
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.

Primary outcomes:
measure: Change From Baseline in the Mean Number of Total Migraine Days Per Month in the Last 4 Weeks of the DBT Phase
timeFrame: OP and Weeks 9 to 12 of the DBT phase
Secondary outcomes:
measure: Number of Participants Who Had ≥ 50% Reduction in Moderate or Severe Migraine Days Per Month in the Last 4 Weeks of the DBT Phase
timeFrame: OP and Weeks 9 to 12 of the DBT phase
measure: Change From Baseline in the Mean Number of Migraine Days Per Month Over the Entire Course of the DBT Phase
timeFrame: OP and Weeks 1 to 12 of the DBT phase
measure: Frequency of Use of Rescue Medication Days Per Month in the Last Month of the DBT Phase
timeFrame: Weeks 9 to 12 of the DBT phase
measure: Change From Baseline in the Mean Number of Total Migraine Days Per Month in the First Month of the DBT Phase
timeFrame: OP and Weeks 1 to 4 of the DBT phase
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation in the DBT Phase
timeFrame: Weeks 1 to 12 of the DBT phase
measure: Number of Participants With AEs, SAEs, AEs Leading to Study Drug Discontinuation in the OLE Phase
timeFrame: OLE Phase (Weeks 13 through 64)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
timeFrame: Weeks 1 to 12 of the DBT phase
measure: Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
timeFrame: OLE Phase (Weeks 13 through 64)
measure: Number of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin (TBL) > 2 x ULN During the DBT Phase
timeFrame: Weeks 1 to 12 of the DBT phase
measure: Percentage of Participants With Elevations of AST or ALT > 3 x ULN Concurrent With TBL > 2 x ULN During the OLE Phase
timeFrame: OLE Phase (Weeks 13 through 64)
measure: Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the DBT Phase
timeFrame: Weeks 1 to 12 of the DBT phase
measure: Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the OLE Phase
timeFrame: OLE Phase (Weeks 13 through 64)
measure: Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase
timeFrame: Baseline, Week 12 of the DBT Phase
measure: Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase
timeFrame: Baseline, Week 12 of the DBT Phase
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MDFirst Research-Chandler
state: Arizona
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Apple Valley
country: United States
facility: Axiom Research, LLC
state: California
city: Colton
country: United States
facility: Axiom Research, LLC
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group
state: California
city: Stamford
country: United States
facility: Ki Health Partners, LLC, dba New England Institute for Clinical Research
state: Connecticut
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Miami
country: United States
facility: Qps Mra, Llc
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Tampa
country: United States
facility: JSV Clinical Research Study Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials, Inc
state: Idaho
city: Idaho Falls
country: United States
facility: R&R Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Wauconda
country: United States
facility: Family Medicine Specialists/CIS
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Prairie Village
country: United States
facility: Phoenix Medical Research
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Chalmette
country: United States
facility: Crescent City Headache and Neurology Center
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc.
state: Massachusetts
city: North Attleboro
country: United States
facility: Regeneris Medical
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Michigan Pain Consultants
state: Michigan
city: Biloxi
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals, Inc.
state: Missouri
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Nevada Headache Institute
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC
state: New York
city: Plainview
country: United States
facility: Island Neurological, A Division of Prohealth Care Associates, LLP
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Greensboro
country: United States
facility: PharmQuest, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Institute Center, Inc.
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Hometown Urgent Care
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics Research
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research, Inc
state: Ohio
city: Norman
country: United States
facility: Oklahoma Headache Center
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Lincoln
country: United States
facility: BTC of Lincoln, LLC
state: Rhode Island
city: Dillon
country: United States
facility: OnSite Clinical Solutions
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research
state: South Dakota
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Frisco
country: United States
facility: North Texas Institute of Neurology & Headache
state: Texas
city: Houston
country: United States
facility: Victorium Clinical Research
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: McLean
country: United States
facility: MedStar Georgetown Headache - Georgetown University
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Women's
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
Study officials:
References:
citation: 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.