Clinical trial NCT03237845: Safety and Efficacy in Adult Subjects With Acute Migraines
Official title: BHV3000-302 : Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) 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: 2017-08-03
Enrollment: 1499
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) versus placebo in subjects with Acute Migraines


Eligibility criteria: Key Inclusion Criteria:

1. Patient 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:

   * 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.

Key Exclusion Criteria:

1. Patient history of HIV disease
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 malabsorption.
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, hepatitisB 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 ofthe 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 thepast 12 months from the date of the screening visit.

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
Secondary outcomes:
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 Phonophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Pain Relief at 2 Hours Post-dose
timeFrame: 2 hours 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 Rescue Medication Use Within 24 Hours Post-dose
timeFrame: 24 hours 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 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 Pain Freedom From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 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 Pain Relapse From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose
timeFrame: 2 hours post-dose
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: Glendale
country: United States
facility: Thunderbird Internal Medicine / Radiant Research, Inc.
state: Arizona
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC
state: Arkansas
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: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Oakland
country: United States
facility: Pacific Research Partners LLC
state: California
city: Panorama City
country: United States
facility: National Research Institute
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Denver
country: United States
facility: Clinical Trials of the Rockies
state: Colorado
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
facility: Radiant Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: Savannah Neurology Specialists
state: Georgia
city: Champaign
country: United States
facility: Christie Clinic, LLC
state: Illinois
city: Ames
country: United States
facility: PMG Research of McFrland Clinic
state: Iowa
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Park City
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Fall River
country: United States
facility: NECCR Primacare Research, LLC
state: Massachusetts
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Jamaica
country: United States
facility: Radiant Research, Inc.
state: New York
city: Raleigh
country: United States
facility: PMG Research of Raleigh, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
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: 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: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Scranton
country: United States
facility: Fieve Clinical Research, Inc.
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: Magnolia
country: United States
facility: PCP for Life
state: Texas
city: Mesquite
country: United States
facility: Research Across America
state: Texas
city: Plano
country: United States
facility: Doctors of Internal Medicine, LTD / Radiant Research, Inc.
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
Study officials:
References:
citation: Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090.