Clinical trial NCT03461757: Trial in Adult Subjects With Acute Migraines
Official title: BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine, With or Without Aura
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-03-12
Enrollment: 1811
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.


Eligibility criteria: Key Inclusion Criteria:

1. 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:

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.

Key Exclusion Criteria:

1. Subject with a history of HIV disease
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

Primary outcomes:
measure: Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: Percentage of Participants With Pain Relief at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
timeFrame: From 2 hours up to 24 hours post-dose
measure: Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose
timeFrame: From 2 hours up to 24 hours post-dose
measure: Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
timeFrame: 24 hours post-dose
measure: Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose
timeFrame: From 2 hours up to 24 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose
timeFrame: 90 minutes post-dose
measure: Percentage of Participants With Pain Relief at 90 Minutes Post-dose
timeFrame: 90 minutes post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
timeFrame: From 2 hours up to 24 hours post-dose
measure: Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose
timeFrame: 90 minutes post dose
measure: Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose
timeFrame: 90 minutes post-dose
measure: Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Percentage of Participants With Pain Relief at 60 Minutes Post-dose
timeFrame: 60 minutes post-dose
measure: Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose
timeFrame: 60 minutes post-dose
measure: Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, LLC
state: Alabama
city: Tempe
country: United States
facility: Clinical Research Consortium, An AMR Company
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group, LLC
state: Arkansas
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: National City
country: United States
facility: Synergy San Diego
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners LLC DBA New England Institute for Clinical Research
state: Connecticut
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
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: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research
state: Florida
city: Atlanta
country: United States
facility: Synexus
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Augusta
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Chalmette
country: United States
facility: Cresent City Headache and Neurology Center LLC
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: Fall River
country: United States
facility: NECCR Primacare Research, LLC
state: Massachusetts
city: Marlborough
country: United States
facility: Community Clinical Research Network/Milford Emergency Associates, Inc
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research, LLC
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: Jamaica
country: United States
facility: CNS Research Science, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Greensboro
country: United States
facility: PharmQuest, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health, PLLC
state: North Carolina
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research
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: Nashville
country: United States
facility: Clinical Research Institute, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc
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: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
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: Health, Research, Gynecology
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
Study officials:
References:
citation: 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.
citation: 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.