A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine

ClinicalTrials.gov processed this data on May 16, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

(See Contacts and Locations)
Verified May 2023 by Pfizer



Information Provided by (Responsible Party)


Clinicaltrials.gov Identifier

Other Study ID Numbers: BHV3500-202
First Submitted: May 26, 2020
First Posted: May 29, 2020
Results First Posted: March 16, 2023
Last Update Posted: May 18, 2023
Last Verified: May 2023
History of Changes

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Study Description

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

Study Design

Study TypeInterventional
Actual Enrollment974 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine
Study Start DateJune 29, 2020
Actual Primary Completion DateDecember 9, 2021
Actual Study Completion DateDecember 23, 2021

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Zavegepant (BHV-3500)
    • 10 mg intranasal (IN) up to 8 times per month, up to 1 year
  • Drug: Zavegepant (BHV-3500)
    • 10 mg IN up to 8 times per month, up to 1 year

Outcome Measures

Primary Outcome Measures

  1. Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation [From study drug dosing up to the end of the study (up to 52 weeks)]
    An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes.
  2. Number Of Participants With Clinically Significant Laboratory Abnormalities [From study drug dosing up to the end of the study (up to 52 weeks)]
    Clinically significant laboratory abnormalities were defined as Grades 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome. Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, low-density lipoprotein (LDL)-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in to be included for a given parameter. Laboratory results were presented in US units.

Eligibility Criteria

Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
Inclusion Criteria
  • 2-8 moderate to severe migraines/month within the last 3 months
  • Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
  • Migraine attacks, on average, lasting about 4-72 hours if untreated
  • Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
  • Ability to distinguish migraine attacks from tension/cluster headaches
  • Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria
Exclusion Criteria
  • History of human immunodeficiency virus disease
  • History of basilar or hemiplegic migraine
  • Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
  • History of nasal surgery in the 6 months preceding the screening visit
  • History of gallstones or cholecystectomy
  • History of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etcetera), or other disease or condition (for example, chronic pancreatitis, ulcerative colitis, etcetera) that causes malabsorption.
  • Body mass index ≥ 33
  • Hemoglobin A1c ≥6.5%

Contacts and Locations

Sponsors and Collaborators Pfizer
  • Medical Affiliated Research Center | Huntsville, Alabama, United States, 35801
  • Coastal Clinical Research, LLC, An AMR Co. | Mobile, Alabama, United States, 36608
  • Tucson Neuroscience Research | Tucson, Arizona, United States, 85710
  • Baptist Health Center for Clinical Research | Little Rock, Arkansas, United States, 72205
  • Pharmacology Research Institute | Encino, California, United States, 91316
  • eStudySite | La Mesa, California, United States, 91942
  • Synergy San Diego | Lemon Grove, California, United States, 91945
  • Collaborative Neuroscience Network, LLC | Long Beach, California, United States, 90806
  • Pharmacology Research Institute | Los Alamitos, California, United States, 90720
  • Wr-Pri, Llc | Newport Beach, California, United States, 92660
  • Artemis Institute for Clinical Research | San Diego, California, United States, 92103
  • Artemis Institute for Clinical Research | San Marcos, California, United States, 92078
  • California Medical Clinic for Headache | Santa Monica, California, United States, 90404
  • California Neuroscience Research Medical Group, Inc. | Sherman Oaks, California, United States, 91403
  • CT Clinical Research | Cromwell, Connecticut, United States, 06416
  • Ki Health Partners, LLC dba New England Institute for Clinical Research | Stamford, Connecticut, United States, 06905
  • Clinical Neuroscience Solutions, Inc. | Jacksonville, Florida, United States, 32256
  • Multi-Specialty Research Associates, Inc. | Lake City, Florida, United States, 32055
  • Clinical Neuroscience Solutions, Inc. | Orlando, Florida, United States, 32801
  • Clinical Neuroscience Solutions, Inc. | Orlando, Florida, United States, 32819
  • Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach, Florida, United States, 32174
  • Meridien Research | Tampa, Florida, United States, 33634
  • iResearch Atlanta, LLC | Decatur, Georgia, United States, 30030
  • Meridian Clinical Research, LLC | Savannah, Georgia, United States, 31406
  • Northwest Clinical Trials Inc. | Boise, Idaho, United States, 83704
  • Community Hospital of Anderson and Madison County Inc | Anderson, Indiana, United States, 46011
  • Fort Wayne Neurological Center | Fort Wayne, Indiana, United States, 46804
  • Collective Medical Research | Prairie Village, Kansas, United States, 66208
  • Crescent City Headache and Neurology Center | Chalmette, Louisiana, United States, 70043
  • Boston Clinical Trials | Boston, Massachusetts, United States, 02131
  • Community Clinical Research Network | Marlborough, Massachusetts, United States, 01752
  • Boston Neuro Research Center | South Dartmouth, Massachusetts, United States, 02747
  • Medvadis Research Corporation | Waltham, Massachusetts, United States, 02451
  • Michigan Headache and Neurological Institute | Ann Arbor, Michigan, United States, 48104
  • Clinical Research Institute, Inc. | Minneapolis, Minnesota, United States, 55402
  • Sundance Clinical Research, LLC | Saint Louis, Missouri, United States, 63141
  • StudyMetrix Research | Saint Peters, Missouri, United States, 63303
  • Clinvest Research LLC | Springfield, Missouri, United States, 65810
  • Dartmouth-Hitchcock Heater Road | Lebanon, New Hampshire, United States, 03766
  • Albuquerque Clinical Trials, Inc. | Albuquerque, New Mexico, United States, 87102
  • Montefiore Medical Center: Headache Center | Bronx, New York, United States, 10461
  • Regional Clinical Research | Endwell, New York, United States, 13760
  • Fieve Clinical Research, Inc | New York, New York, United States, 10017
  • Rochester Clinical Research, Inc. | Rochester, New York, United States, 14609
  • Headache Wellness Center | Greensboro, North Carolina, United States, 27405
  • PharmQuest LLC | Greensboro, North Carolina, United States, 27408
  • Wilmington Health, PLLC | Wilmington, North Carolina, United States, 28401
  • OK Clinical Research LLC | Edmond, Oklahoma, United States, 73034
  • Tekton Research, Inc. | Yukon, Oklahoma, United States, 73099
  • Summit Research Network | Portland, Oregon, United States, 97210
  • Clinical Research of Philadelphia, LLC | Philadelphia, Pennsylvania, United States, 19114
  • Preferred Primary Care Physicians, Inc. | Pittsburgh, Pennsylvania, United States, 15236
  • Preferred Primary Care Physicians, Inc. | Union, Pennsylvania, United States, 15401
  • Coastal Carolina Research Center | Mount Pleasant, South Carolina, United States, 29464
  • Volunteer Research Group | Knoxville, Tennessee, United States, 37920
  • 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
  • Red Star Research LLC | Lake Jackson, Texas, United States, 77566
  • DM Clinical Research | Tomball, Texas, United States, 77375
  • Wasatch Clinical Research, LLC | Salt Lake City, Utah, United States, 84107
  • J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan, Utah, United States, 84095
  • Charlottesville Medical Research Center, LLC | Charlottesville, Virginia, United States, 22911
  • Tidewater Integrated Medical Research | Virginia Beach, Virginia, United States, 23454
  • Northwest Clinical Research Center | Bellevue, Washington, United States, 98007
  • Seattle Women's: Health, Research, Gynecology | Seattle, Washington, United States, 98105
  • Clinical Investigation Specialist, Inc. | Kenosha, Wisconsin, United States, 53144

Study Documents (Full Text)

More Information

Additional Relevant MeSH Terms

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