A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
- Conditions
- Migraine
- Interventions
- Drug: BHV-3500 (zavegepant)Drug: Placebo
- Registration Number
- NCT04804033
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 538
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:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4 - 72 hours if untreated
- Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit
- Eight or more migraine days during the Observation Period
- 15 or more headache days during the Observation Period
- One or more non-headache days during the Observation Period
- Ability to distinguish migraine attacks from tension/cluster headaches
- 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.
- Subject with a history of HIV disease
- 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
- 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).
- Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. 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.
- Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy.
- Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
- Body mass index > 33 kg/m2
- History of gallstones or cholecystectomy.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BHV-3500 200mg BHV-3500 (zavegepant) Zavegepant 200mg oral soft gel capsule. Placebo 200mg Placebo Matching placebo 200mg oral soft gel capsule. BHV-3500 100mg BHV-3500 (zavegepant) Zavegepant 100mg oral soft gel capsule. Placebo 100mg Placebo Matching placebo 100mg oral soft gel capsule.
- Primary Outcome Measures
Name Time Method Efficacy of zavegepant compared to placebo as a preventive treatment for migraine Number of migraine during weeks 1 to 12 Measured by the mean reduction from baseline (i.e., Observation Phase) in the number of migraine days per month over the entire Double-blind Treatment Phase.
- Secondary Outcome Measures
Name Time Method Efficacy of zavegepant compared to placebo with the number of subjects that had a ≥ 50% reduction from Observational Phase. Number of migraine days during weeks 1 to 12 Measured by the number of moderate to severe migraine days per month over the entire double-blind treatment phase.
Efficacy of zavegepant to placebo on mean reduction from Observational Phase. Number of migraine days per month during weeks 1 to 4 Measured by the number of migraine days per month in the first 4 weeks of the Double-Blind Treatment Phase.
Efficacy of zavegepant to placebo in the mean number of acute migraine specific medication days per month. Number of migraine days per month during weeks 1 to 12 Measured by the number of acute migraine specific medication days over the entire Double-Blind Treatment Phase.
Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase. Week 12 of the double-blind treatment phase. The change from baseline is calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline.
Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase. Week 12 of the double-blind treatment phase. The change from baseline is calculated as the MIDAS total score at Week 12 of the DBT phase minus the MIDAS total score at baseline.
Evaluate the safety and tolerability of zavegepant. From Baseline through Week 12 This will be evaluated by the number of participants with treatment related adverse events by severity measured as mild, moderate, or severe.
The frequency of ALT or AST elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN in subjects treated with zavegepent during the double-blind and open label phases. From Baseline through Week 12 The frequency of hepatic related adverse events. From Baseline through Week 12 Measured by discontinuations in subjects treated with zavegepant due to elevated Liver Function Tests during the double-blind and open label phases
Trial Locations
- Locations (102)
Clinical Research Philadelphia, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Meridian Clinical Research, LLC
🇺🇸Norfolk, Virginia, United States
Clinical Investigation Specialists, Inc
🇺🇸Gurnee, Illinois, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Tucson Neuroscience Research
🇺🇸Tucson, Arizona, United States
Alliance for Multispecialty Research, LLC
🇺🇸Newton, Kansas, United States
Romedica LLC
🇺🇸Rochester, Michigan, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
North Suffolk Neurology, PC
🇺🇸Port Jefferson Station, New York, United States
Kansas Institute of Research
🇺🇸Overland Park, Kansas, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Reading Hospital Clinical Trials Office
🇺🇸West Reading, Pennsylvania, United States
Collevtive Medical Research
🇺🇸Overland Park, Kansas, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
M3 Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸North Canton, Ohio, United States
Clinical Investigation Specialists, Inc.
🇺🇸Gurnee, Illinois, United States
Dent Neurosciences Research Center, Inc.
🇺🇸Amherst, New York, United States
North Texas Institute of Neurology and Headache - NextStage Clinical Research
🇺🇸Frisco, Texas, United States
Radiance Clinical Research
🇺🇸Lampasas, Texas, United States
Red Star Research. LLC
🇺🇸Lake Jackson, Texas, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
MediSphere Medical Research Center, LLC.
🇺🇸Evansville, Indiana, United States
Tower Health Medical Group - Neurology
🇺🇸West Reading, Pennsylvania, United States
Internal Medicine and Pediatric Associates of Bristol, PC
🇺🇸Bristol, Tennessee, United States
Crescent City Headache and Neurology Center
🇺🇸Chalmette, Louisiana, United States
Community Clinical Research Network Inc
🇺🇸Marlborough, Massachusetts, United States
Carolina Research Center, Inc.
🇺🇸Shelby, North Carolina, United States
Neurology Center of New England P.C.
🇺🇸Foxboro, Massachusetts, United States
Accellacare (Administrative Only)
🇺🇸Bristol, Tennessee, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
WellNow Urgent Care and Research
🇺🇸Troy, Ohio, United States
New York Neurology Associates
🇺🇸New York, New York, United States
FMC Science
🇺🇸Lampasas, Texas, United States
Clinvest Research, LLC
🇺🇸Springfield, Missouri, United States
Fieve Clinical Research, Inc
🇺🇸New York, New York, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
KCA Neurology, PLLC
🇺🇸Franklin, Tennessee, United States
North Texas Institute of Neurology and Headache
🇺🇸Frisco, Texas, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Wellnow Urgent Care and Research
🇺🇸Columbus, Ohio, United States
Preferred Primary Care Physicians, Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
Seattle Clinical Research Center
🇺🇸Seattle, Washington, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Brainstorm Research
🇺🇸Miami, Florida, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Excel Clinical research
🇺🇸Las Vegas, Nevada, United States
Wr-Crcn, Llc
🇺🇸Las Vegas, Nevada, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Wellnow Urgent Care
🇺🇸Cincinnati, Ohio, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
Summit Headlands LLC, dba Summit Research
🇺🇸Portland, Oregon, United States
Wasatch Clinical Research , LLC(Administrative Location)
🇺🇸Salt Lake City, Utah, United States
Upstate Clinical Research Associates, LLC
🇺🇸Williamsville, New York, United States
Xenoscience, Inc
🇺🇸Phoenix, Arizona, United States
Wr-Pri, Llc
🇺🇸Newport Beach, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
eStudySite
🇺🇸La Mesa, California, United States
Axiom Research, Llc
🇺🇸Colton, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Collaborative Neuroscience Research, LLC.
🇺🇸Long Beach, California, United States
Clinical Research Institute
🇺🇸Los Angeles, California, United States
California Neuroscience Research Medical Group, inc.
🇺🇸Sherman Oaks, California, United States
CMR of Greater New Haven, LLC
🇺🇸Hamden, Connecticut, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Neurology Offices of South Florida
🇺🇸Boca Raton, Florida, United States
Accel Research Sites Network - Edgewater Clinical Research Unit
🇺🇸Edgewater, Florida, United States
Complete Health Research
🇺🇸Ormond Beach, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
AppleMed Research Group, LLC
🇺🇸Miami, Florida, United States
Ideal Clinical Research
🇺🇸Pembroke Pines, Florida, United States
The Neurology Research Group
🇺🇸Miami, Florida, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Accel Research Sites Network - St. Petersburg Clinical Research Unit
🇺🇸Saint Petersburg, Florida, United States
Clin-Med Research & Development LLC
🇺🇸South Miami, Florida, United States
iResearch Atlanta LLC
🇺🇸Decatur, Georgia, United States
CenExel iResearch, LLC
🇺🇸Decatur, Georgia, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Seattle Women's: Health, Research, Gynecology
🇺🇸Seattle, Washington, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
JSV Clinical Research Study Inc
🇺🇸Tampa, Florida, United States
Michigan Head Pain & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Alliance for Multispecialty Reseach, LLC
🇺🇸Kansas City, Missouri, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Alliance for Multispecialty Research, LLC.
🇺🇸New Orleans, Louisiana, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
The Research Group of Lexington, Llc.
🇺🇸Lexington, Kentucky, United States
The Research Group of Lexington, Llc
🇺🇸Lexington, Kentucky, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States