Clinical trial NCT03235479: Safety and Efficacy Study in Adult Subjects With Acute Migraines
Official title: BHV3000-301: 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: 2017-08-01
Enrollment: 1485
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 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.

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 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: Birmingham
country: United States
facility: Central Research Associates, Inc
state: Alabama
city: Gilbert
country: United States
facility: Neurological Physicians of Arizona/Radiant Research Inc
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Consortium Arizona
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
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: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc
state: California
city: Hollywood
country: United States
facility: Qps Mra, Llc
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: Advanced Pharma CR, LLC
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials, Inc
state: Massachusetts
city: Marlborough
country: United States
facility: Milford Emergency Associates, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc
state: Minnesota
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research -Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium- Las Vegas
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: New York
country: United States
facility: Fieve Clinical Research
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: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
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: Austin
country: United States
facility: FutureSearch Trials of Neurology, LP
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Neurology, LP
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development
state: Texas
city: Salt Lake City
country: United States
facility: J.Lewis Research Inc / Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J.Lewis Research Inc. / Jordan River Family Med
state: Utah
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater, Inc.
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
Study officials:
References: