Double-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine

ClinicalTrials.gov processed this data on April 20, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
 (See Contacts and Locations)
Verified April 2023 by Pfizer

Sponsor

Pfizer

Information Provided by (Responsible Party)

Pfizer

Clinicaltrials.gov Identifier

NCT04571060
Other Study ID Numbers: BHV3500-301
First Submitted: September 11, 2020
First Posted: September 30, 2020
Results First Posted: March 16, 2023
Last Update Posted: April 24, 2023
Last Verified: April 2023
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Migraine
  • Drug: Zavegepant
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment1978 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleDouble-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine
Study Start DateOctober 27, 2020
Actual Primary Completion DateOctober 10, 2021
Actual Study Completion DateOctober 22, 2021

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Zavegepant
    • Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar Unidose System (UDS) liquid spray device.
  • Drug: Zavegepant
    • One dose of zavegepant
  • Placebo
    • Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
  • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Freedom From Pain at 2 Hours Post-dose [2 hours post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.
    2. Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose [2 hours post-dose]
      MBS was reported as nausea, photophobia, or phonophobia immediately before dosing using the eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack onset that was absent post-dose.

    Secondary Outcome Measures

    1. Percentage of Participants With Pain Relief at 2 Hours Post-dose [2 hours post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.
    2. Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose [2 hours post-dose]
      Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.
    3. Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose [From 2 to 24 hours post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose.
    4. Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose [From 2 to 48 hours post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose.
    5. Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose [From 2 to 24 hours post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose.
    6. Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose [From 2 to 48 hours post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose.
    7. Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose [2 hours post-dose]
      Phonophobia (sensitivity to sound) status was measured as absent or present in the eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset.
    8. Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose [2 hours post-dose]
      Photophobia (sensitivity to light) status was measured as absent or present in the eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset.
    9. Percentage of Participants With Pain Relief at 60 Minutes Post-dose [60 minutes post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.
    10. Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose [60 minutes post-dose]
      Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) present at on-study migraine attack onset.
    11. Percentage of Participants With Pain Relief at 30 Minutes Post-dose [30 minutes post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.
    12. Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose [30 minutes post-dose]
      Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.
    13. Percentage of Participants With Pain Relief at 15 Minutes Post-dose [15 minutes post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.
    14. Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose [15 minutes post-dose]
      Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.
    15. Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose [Through 24 hours post-dose]
      Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eCOA handheld device) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin® Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form.
    16. Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose [2 hours post-dose]
      Nausea status was measured as absent or present in the eCOA handheld device. Freedom from nausea was defined as nausea absent post-dose in the subset of participants with nausea present at on-study migraine attack onset.
    17. Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose [From 2 hours to 48 hours post-dose]
      Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose in the subset of participants with pain level of none at 2 hours post-dose.

    Eligibility Criteria

    Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • Participant 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, including the following:
    • Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
    • Migraine attacks, on average, lasting about 4-72 hours if untreated
    • Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
    • At least 2 consistent 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
    • 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.
    • Participants 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 screening visit and the dose is not expected to change during the course of the study.
    • Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
    • Male and Female participants ≥18 years of age.
    Exclusion Criteria
    • Participant with a history of HIV disease
    • Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Participants 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 participants can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled).
    • Participants with major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder.
    • History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or participants who have met DSM-V criteria for any significant substance use disorder within the past 12 months.
    • History of nasal surgery in the 6 months.
    • Evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g. severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma)
    • Participation in any other investigational clinical trial while participating in this clinical trial. Participation in a COVID-19 mRNA vaccine study (vaccine must be authorized under FDA emergency use authorization or approval) who are at least 30 days post last dose of the vaccine are permitted to be screened for this study.

    Contacts and Locations

    Sponsors and Collaborators Pfizer
    Locations
    • Medical Affiliated Research Center | Huntsville, Alabama, United States, 35801
    • Coastal Clinical Research, LLC, An AMR Co. | Mobile, Alabama, United States, 36608
    • MD First Research | Chandler, Arizona, United States, 85286
    • Tucson Neuroscience Research | Tucson, Arizona, United States, 85710
    • Baptist Health Center for Clinical Research | Little Rock, Arkansas, United States, 72205
    • Axiom Research, LLC | Colton, California, United States, 92324
    • 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
    • Clinical Research Institute | Los Angeles, California, United States, 90404
    • Wr-Pri, Llc | Newport Beach, California, United States, 92660
    • Artemis Institute for Clinical Research | Riverside, California, United States, 92503
    • Artemis Institute for Clinical Research | San Diego, California, United States, 92103
    • 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, 06095
    • Neurology Offices of South Florida | Boca Raton, Florida, United States, 33428
    • Clinical Neuroscience Solutions, Inc. | Jacksonville, Florida, United States, 32256
    • Multi-Specialty Research Associates, Inc. | Lake City, Florida, United States, 32055
    • Meridien Research | Lake Mary, Florida, United States, 32746
    • AppleMed Research Group, LLC | Miami, Florida, United States, 33155
    • The Neurology Research Group | Miami, Florida, United States, 33176
    • Clinical Neuroscience Solutions, Inc. | Orlando, Florida, United States, 32801
    • Clinical Neuroscience Solutions, Inc. | Orlando, Florida, United States, 32819
    • 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
    • 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
    • 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
    • Cedar Crosse Research Center | Chicago, Illinois, United States, 60607
    • Healthcare Research Network II, LLC | Flossmoor, Illinois, United States, 60422
    • Fort Wayne Neurological Center | Fort Wayne, Indiana, United States, 46804
    • Collective Medical Research | Prairie Village, Kansas, United States, 66208
    • Alliance for Multispecialty Research, LLC | Wichita, Kansas, United States, 67205
    • L-MARC Research Center | Louisville, Kentucky, United States, 40213
    • Crescent City Headache and Neurology Center | Chalmette, Louisiana, United States, 70043
    • DelRicht Research | New Orleans, Louisiana, United States, 70124
    • 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
    • Healthcare Research Network | Hazelwood, Missouri, United States, 63042
    • 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
    • Excel Clinical Research | Las Vegas, Nevada, United States, 89109
    • Center for Emotional Fitness | Cherry Hill, New Jersey, United States, 08002
    • Albuquerque Clinical Trials, Inc. | Albuquerque, New Mexico, United States, 87102
    • Dent Neurosciences Research Center | Amherst, New York, United States, 14226
    • Montefiore Medical Center: Headache Center | Bronx, New York, United States, 10461
    • Regional Clinical Research | Endwell, New York, United States, 13760
    • Central New York Clinical Research | Manlius, New York, United States, 13104
    • 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
    • PMG of Raleigh, LLC | Raleigh, North Carolina, United States, 27609
    • Wilmington Health, PLLC | Wilmington, North Carolina, United States, 28401
    • Hometown Urgent Care & Research/ Wellnow | Cincinnati, Ohio, United States, 45215
    • Hometown Urgent Care and Research | Columbus, Ohio, United States, 43214
    • Hometown Urgent Care and Research | Dayton, Ohio, United States, 45424
    • The Orthopedic Foundation | New Albany, Ohio, United States, 43054
    • 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
    • MD First Research | Lancaster, South Carolina, United States, 29720
    • 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
    • Donald J. Garcia, Jr, MD, PA | Austin, Texas, United States, 78737
    • FutureSearch Trials of Dallas, LP | Dallas, Texas, United States, 75231
    • Red Star Research LLC | Lake Jackson, Texas, United States, 77566
    • Clinical Trials of Texas, Inc. (CTT) | San Antonio, Texas, United States, 78229
    • DM Clinical Research | Tomball, Texas, United States, 77375
    • Alpine Medical Group | 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
    • Health Research of Hampton Roads, Inc. | Newport News, Virginia, United States, 23606
    • 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