A Phase 2/3 Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

ClinicalTrials.gov processed this data on July 10, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

TERMINATED (See Contacts and Locations)
Verified July 2024 by Pfizer

Sponsor

Pfizer

Information Provided by (Responsible Party)

Pfizer

Clinicaltrials.gov Identifier

NCT04804033
Other Study ID Numbers: BHV3500-302
First Submitted: March 5, 2021
First Posted: March 18, 2021
Last Update Posted: July 11, 2024
Last Verified: July 2024
History of Changes

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.

Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.

Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.

For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.

See also the Web Policies and Notices for the NIH web site.

Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Migraine
  • Drug: BHV-3500 (zavegepant)
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment538 participants
Design AllocationRandomized
Interventional ModelSequential Assignment
MaskingQuadruple
Primary PurposePrevention
Official TitleA Phase 2/3 Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Study Start DateMarch 26, 2021
Actual Primary Completion DateMarch 21, 2024
Actual Study Completion DateMarch 21, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • BHV-3500 200mg
    • Zavegepant 200mg oral soft gel capsule.
  • Drug: BHV-3500 (zavegepant)
    • BHV-3500 (zavegepant) softgel capsule.
  • Placebo 200mg
    • Matching placebo 200mg oral soft gel capsule.
  • Drug: Placebo
    • BHV-3500 100mg
      • Zavegepant 100mg oral soft gel capsule.
    • Drug: BHV-3500 (zavegepant)
      • BHV-3500 (zavegepant) softgel capsule.
    • Placebo 100mg
      • Matching placebo 100mg oral soft gel capsule.
    • Drug: Placebo

      Outcome Measures

      Primary Outcome Measures

      1. 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

      1. 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.
      2. Efficacy of zavegepant to placebo on mean reduction from Observational Phase. [Number of migraine days during per month during weeks 9 to 12]
        Measured by the number of migraine days in the last 4 weeks of the Double-Blind Treatment Phase.
      3. 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.
      4. 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.
      5. 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.
      6. 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.
      7. 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.
      8. 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]
      9. 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

      Eligibility Criteria

      Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
      Sexes Eligible for Study All
      Accepts Healthy Volunteers No
      Inclusion Criteria
      • 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.
      Exclusion Criteria
      • 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

      Contacts and Locations

      Sponsors and Collaborators Pfizer
      Locations
      • Xenoscience, Inc | Phoenix, Arizona, United States, 85004
      • Tucson Neuroscience Research | Tucson, Arizona, United States, 85710
      • Hope Clinical Research | Canoga Park, California, United States, 91303
      • Axiom Research, Llc | Colton, California, United States, 92324
      • Wr-Pri, Llc | Encino, California, United States, 91316
      • eStudySite | La Mesa, California, United States, 91942
      • Synergy San Diego | Lemon Grove, California, United States, 91945
      • Collaborative Neuroscience Research, LLC. | Long Beach, California, United States, 90806
      • Clinical Research Institute | Los Angeles, California, United States, 90048
      • Wr-Pri, Llc | Newport Beach, California, United States, 92660
      • Artemis Institute for Clinical Research | San Diego, California, United States, 92103
      • California Neuroscience Research Medical Group, inc. | Sherman Oaks, California, United States, 91403
      • CMR of Greater New Haven, LLC | Hamden, Connecticut, United States, 06517
      • Ki Health Partners, LLc, dba New England Institute for Clinical Research | Stamford, Connecticut, United States, 06905
      • Chase Medical Research, LLC | Waterbury, Connecticut, United States, 06708
      • Neurology Offices of South Florida | Boca Raton, Florida, United States, 33428
      • Accel Research Sites Network - Edgewater Clinical Research Unit | Edgewater, Florida, United States, 32132
      • Complete Health Research | Edgewater, Florida, United States, 32132
      • Sarkis Clinical Trials | Gainesville, Florida, United States, 32607
      • Clinical Neuroscience Solutions, Inc. | Jacksonville, Florida, United States, 32256
      • Multi-Specialty Research Associates, Inc. | Lake City, Florida, United States, 32055
      • AppleMed Research Group, LLC | Miami, Florida, United States, 33126
      • AppleMed Research Group, LLC | Miami, Florida, United States, 33155
      • Brainstorm Research | Miami, Florida, United States, 33176
      • The Neurology Research Group | Miami, Florida, United States, 33176
      • Clinical Neuroscience Solutions, Inc. | Orlando, Florida, United States, 32801
      • Complete Health Research | Ormond Beach, Florida, United States, 32174
      • Ideal Clinical Research | Pembroke Pines, Florida, United States, 33026
      • Clinical Research Center of Florida | Pompano Beach, Florida, United States, 33060
      • Accel Research Sites Network - St. Petersburg Clinical Research Unit | Saint Petersburg, Florida, United States, 33709
      • Clin-Med Research & Development LLC | South Miami, Florida, United States, 33143
      • ForCare Clinical Research | Tampa, Florida, United States, 33613
      • JSV Clinical Research Study Inc | Tampa, Florida, United States, 33634
      • CenExel iResearch, LLC | Decatur, Georgia, United States, 30030
      • iResearch Atlanta LLC | Decatur, Georgia, United States, 30030
      • Cedar Crosse Research Center | Chicago, Illinois, United States, 60607
      • Clinical Investigation Specialists, Inc. | Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists, Inc | Gurnee, Illinois, United States, 60031
      • MediSphere Medical Research Center, LLC. | Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC | Evansville, Indiana, United States, 47714
      • Meridian Clinical Research, LLC | Sioux City, Iowa, United States, 51106
      • Alliance for Multispecialty Reseach, LLC | El Dorado, Kansas, United States, 67042
      • Alliance for Multispecialty Research, LLC | Newton, Kansas, United States, 67114
      • Collevtive Medical Research | Overland Park, Kansas, United States, 66210
      • Kansas Institute of Research | Overland Park, Kansas, United States, 66211
      • The Research Group of Lexington, Llc. | Lexington, Kentucky, United States, 40503
      • The Research Group of Lexington, Llc | Lexington, Kentucky, United States, 40503
      • L-MARC Research Center | Louisville, Kentucky, United States, 40213
      • Crescent City Headache and Neurology Center | Chalmette, Louisiana, United States, 70043
      • Alliance for Multispecialty Research, LLC. | New Orleans, Louisiana, United States, 70119
      • DelRicht Research | New Orleans, Louisiana, United States, 70124
      • Boston Clinical Trials | Boston, Massachusetts, United States, 02131
      • Neurology Center of New England P.C. | Foxboro, Massachusetts, United States, 02035
      • Community Clinical Research Network Inc | Marlborough, Massachusetts, United States, 01752
      • MedVadis Research Corporation | Waltham, Massachusetts, United States, 02451
      • Michigan Head Pain & Neurological Institute | Ann Arbor, Michigan, United States, 48104
      • Romedica LLC | Rochester, Michigan, United States, 48307
      • Alliance for Multispecialty Reseach, LLC | Kansas City, Missouri, United States, 64114
      • StudyMetrix Research | Saint Peters, Missouri, United States, 63303
      • Clinvest Research, LLC | Springfield, Missouri, United States, 65807
      • Clinvest Research, LLC | Springfield, Missouri, United States, 65810
      • Meridian Clinical Research, LLC | Norfolk, Nebraska, United States, 68701
      • Excel Clinical research | Las Vegas, Nevada, United States, 89109
      • Wr-Crcn, Llc | Las Vegas, Nevada, United States, 89118
      • Albuquerque Clinical Trials, Inc. | Albuquerque, New Mexico, United States, 87102
      • Dent Neurosciences Research Center, Inc. | Amherst, New York, United States, 14226
      • Montefiore Medical Center | Bronx, New York, United States, 10461
      • Central New York Clinical Research | Manlius, New York, United States, 13104
      • New York Neurology Associates | New York, New York, United States, 10003
      • Fieve Clinical Research, Inc | New York, New York, United States, 10017
      • North Suffolk Neurology, PC | Port Jefferson Station, New York, United States, 11776
      • Upstate Clinical Research Associates, LLC | Williamsville, New York, United States, 14221
      • Headache Wellness Center | Greensboro, North Carolina, United States, 27405
      • Accellacare | Raleigh, North Carolina, United States, 27609
      • M3 Wake Research, Inc. | Raleigh, North Carolina, United States, 27612
      • Carolina Research Center, Inc. | Shelby, North Carolina, United States, 28150
      • Accellacare | Wilmington, North Carolina, United States, 28401
      • CTI Clinical Research Center | Cincinnati, Ohio, United States, 45212
      • WellNow Urgent Care and Research | Cincinnati, Ohio, United States, 45215
      • Wellnow Urgent Care | Cincinnati, Ohio, United States, 45215
      • Hometown Urgent Care and Research | Columbus, Ohio, United States, 43214
      • Wellnow Urgent Care and Research | Columbus, Ohio, United States, 43214
      • Hometown Urgent Care and Research | Dayton, Ohio, United States, 45424
      • WellNow Urgent Care and Research | Dayton, Ohio, United States, 45424
      • Neuro-Behavioral Clinical Research, Inc. | North Canton, Ohio, United States, 44720
      • WellNow Urgent Care and Research | Troy, Ohio, United States, 45373
      • Hightower Clinical | Oklahoma City, Oklahoma, United States, 73134
      • Summit Headlands LLC, dba Summit Research | Portland, Oregon, United States, 97210
      • Clinical Research Philadelphia, LLC | Philadelphia, Pennsylvania, United States, 19114
      • Preferred Primary Care Physicians, Inc. | Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians | Uniontown, Pennsylvania, United States, 15401
      • Reading Hospital Clinical Trials Office | West Reading, Pennsylvania, United States, 19611
      • Tower Health Medical Group - Neurology | West Reading, Pennsylvania, United States, 19611
      • Coastal Carolina Research Center | North Charleston, South Carolina, United States, 29405
      • Accellacare (Administrative Only) | Bristol, Tennessee, United States, 37620
      • Internal Medicine and Pediatric Associates of Bristol, PC | Bristol, Tennessee, United States, 37620
      • WR-ClinSearch, LLC | Chattanooga, Tennessee, United States, 37421
      • KCA Neurology, PLLC | Franklin, Tennessee, United States, 37067
      • Clinical Neuroscience Solutions, Inc. | Memphis, Tennessee, United States, 38119
      • FutureSearch Trials of Neurology | Austin, Texas, United States, 78731
      • FutureSearch Trials of Dallas, LP | Dallas, Texas, United States, 75231
      • North Texas Institute of Neurology and Headache | Frisco, Texas, United States, 75034
      • Texas Center for Drug Development, Inc. | Houston, Texas, United States, 77081
      • Red Star Research. LLC | Lake Jackson, Texas, United States, 77566
      • FMC Science | Lampasas, Texas, United States, 76550
      • Radiance Clinical Research | Lampasas, Texas, United States, 76550
      • DM Clinical Research | Tomball, Texas, United States, 77375
      • Wasatch Clinical Research , LLC(Administrative Location) | Salt Lake City, Utah, United States, 84107
      • Charlottesville Medical Research Center, LLC | Charlottesville, Virginia, United States, 22911
      • Health Research of Hampton Roads, Inc. | Newport News, Virginia, United States, 23606
      • Meridian Clinical Research, LLC | Norfolk, Virginia, United States, 23502
      • Northwest Clinical Research Center | Bellevue, Washington, United States, 98007
      • Seattle Clinical Research Center | Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research, Gynecology | Seattle, Washington, United States, 98105
      Investigators

        More Information

        Additional Information

        Additional Relevant MeSH Terms

        • Migraine Disorders
        • Headache Disorders, Primary
        • Headache Disorders
        • Brain Diseases
        • Central Nervous System Diseases
        • Nervous System Diseases