Randomized Trial in Adult Participants With Acute Migraines

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified March 2023 by Pfizer
Sponsor
Pfizer
Information Provided by (Responsible Party)
Pfizer
Clinicaltrials.gov Identifier
NCT04571060
Other Study ID Numbers:
BHV3500-301
First Submitted
September 10, 2020
First Posted
September 29, 2020
Results First Posted
February 16, 2023
Last Update Posted
April 23, 2023
Last Verified
March 2023

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Migraine
Drug: ZavegepantDrug: 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 26, 2020
Actual Primary Completion DateOctober 9, 2021
Actual Study Completion DateOctober 21, 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
One dose of matching placebo

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants With Freedom From Pain at 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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. 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: 1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age 2. Migraine attacks, on average, lasting about 4-72 hours if untreated 3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months 4. 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 5. 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. 6. 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. 7. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria. 2. Male and Female participants ≥18 years of age.
Exclusion Criteria
1. Participant with a history of HIV disease 2. 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. 3. 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). 4. 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. 5. 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. 6. History of nasal surgery in the 6 months. 7. 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) 8. 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 CollaboratorsPfizer
Locations
Medical Affiliated Research Center | Huntsville Alabama, United States, 35801Coastal Clinical Research, LLC, An AMR Co. | Mobile Alabama, United States, 36608MD First Research | Chandler Arizona, United States, 85286Tucson Neuroscience Research | Tucson Arizona, United States, 85710Baptist Health Center for Clinical Research | Little Rock Arkansas, United States, 72205Axiom Research, LLC | Colton California, United States, 92324Pharmacology Research Institute | Encino California, United States, 91316eStudySite | La Mesa California, United States, 91942Synergy San Diego | Lemon Grove California, United States, 91945Collaborative Neuroscience Network, LLC | Long Beach California, United States, 90806Pharmacology Research Institute | Los Alamitos California, United States, 90720Clinical Research Institute | Los Angeles California, United States, 90404Wr-Pri, Llc | Newport Beach California, United States, 92660Artemis Institute for Clinical Research | Riverside California, United States, 92503Artemis Institute for Clinical Research | San Diego California, United States, 92103California Neuroscience Research Medical Group, Inc. | Sherman Oaks California, United States, 91403CT Clinical Research | Cromwell Connecticut, United States, 06416Ki Health Partners, LLC dba New England Institute for Clinical Research | Stamford Connecticut, United States, 06095Neurology Offices of South Florida | Boca Raton Florida, United States, 33428Clinical Neuroscience Solutions, Inc. | Jacksonville Florida, United States, 32256Multi-Specialty Research Associates, Inc. | Lake City Florida, United States, 32055Meridien Research | Lake Mary Florida, United States, 32746AppleMed Research Group, LLC | Miami Florida, United States, 33155The Neurology Research Group | Miami Florida, United States, 33176Clinical Neuroscience Solutions, Inc. | Orlando Florida, United States, 32801Clinical Neuroscience Solutions, Inc. | Orlando Florida, United States, 32819Complete Health Research | Ormond Beach Florida, United States, 32174Ideal Clinical Research | Pembroke Pines Florida, United States, 33026Clinical Research Center of Florida | Pompano Beach Florida, United States, 33060Clin-Med Research & Development, LLC | South Miami Florida, United States, 33143ForCare Clinical Research | Tampa Florida, United States, 33613JSV Clinical Research Study, Inc. | Tampa Florida, United States, 33634iResearch Atlanta, LLC | Decatur Georgia, United States, 30030Meridian Clinical Research, LLC | Savannah Georgia, United States, 31406Northwest Clinical Trials Inc. | Boise Idaho, United States, 83704Cedar Crosse Research Center | Chicago Illinois, United States, 60607Healthcare Research Network II, LLC | Flossmoor Illinois, United States, 60422Fort Wayne Neurological Center | Fort Wayne Indiana, United States, 46804Collective Medical Research | Prairie Village Kansas, United States, 66208Alliance for Multispecialty Research, LLC | Wichita Kansas, United States, 67205L-MARC Research Center | Louisville Kentucky, United States, 40213Crescent City Headache and Neurology Center | Chalmette Louisiana, United States, 70043DelRicht Research | New Orleans Louisiana, United States, 70124Boston Clinical Trials | Boston Massachusetts, United States, 02131Community Clinical Research Network | Marlborough Massachusetts, United States, 01752Boston Neuro Research Center | South Dartmouth Massachusetts, United States, 02747Medvadis Research Corporation | Waltham Massachusetts, United States, 02451Michigan Headache and Neurological Institute | Ann Arbor Michigan, United States, 48104Clinical Research Institute, Inc. | Minneapolis Minnesota, United States, 55402StudyMetrix Research | City of Saint Peters Missouri, United States, 63303Healthcare Research Network | Hazelwood Missouri, United States, 63042Clinvest Research LLC | Springfield Missouri, United States, 65810Sundance Clinical Research, LLC | St Louis Missouri, United States, 63141Excel Clinical Research | Las Vegas Nevada, United States, 89109Center for Emotional Fitness | Cherry Hill New Jersey, United States, 08002Albuquerque Clinical Trials, Inc. | Albuquerque New Mexico, United States, 87102Dent Neurosciences Research Center | Amherst New York, United States, 14226Regional Clinical Research | Endwell New York, United States, 13760Central New York Clinical Research | Manlius New York, United States, 13104Fieve Clinical Research, Inc | New York New York, United States, 10017Rochester Clinical Research, Inc. | Rochester New York, United States, 14609Montefiore Medical Center: Headache Center | The Bronx New York, United States, 10461Headache Wellness Center | Greensboro North Carolina, United States, 27405PharmQuest LLC | Greensboro North Carolina, United States, 27408PMG of Raleigh, LLC | Raleigh North Carolina, United States, 27609Wilmington Health, PLLC | Wilmington North Carolina, United States, 28401Hometown Urgent Care & Research/ Wellnow | Cincinnati Ohio, United States, 45215Hometown Urgent Care and Research | Columbus Ohio, United States, 43214Hometown Urgent Care and Research | Dayton Ohio, United States, 45424The Orthopedic Foundation | New Albany Ohio, United States, 43054OK Clinical Research LLC | Edmond Oklahoma, United States, 73034Tekton Research, Inc. | Yukon Oklahoma, United States, 73099Summit Research Network | Portland Oregon, United States, 97210Clinical Research of Philadelphia, LLC | Philadelphia Pennsylvania, United States, 19114Preferred Primary Care Physicians, Inc. | Pittsburgh Pennsylvania, United States, 15236Preferred Primary Care Physicians, Inc. | Union Pennsylvania, United States, 15401MD First Research | Lancaster South Carolina, United States, 29720Coastal Carolina Research Center | Mt. Pleasant South Carolina, United States, 29464Volunteer Research Group | Knoxville Tennessee, United States, 37920Clinical Neuroscience Solutions, Inc. | Memphis Tennessee, United States, 38119FutureSearch Trials of Neurology | Austin Texas, United States, 78731Donald J. Garcia, Jr, MD, PA | Austin Texas, United States, 78737FutureSearch Trials of Dallas, LP | Dallas Texas, United States, 75231Red Star Research LLC | Lake Jackson Texas, United States, 77566Clinical Trials of Texas, Inc. (CTT) | San Antonio Texas, United States, 78229DM Clinical Research | Tomball Texas, United States, 77375Alpine Medical Group | Salt Lake City Utah, United States, 84107J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan Utah, United States, 84095Charlottesville Medical Research Center, LLC | Charlottesville Virginia, United States, 22911Health Research of Hampton Roads, Inc. | Newport News Virginia, United States, 23606Tidewater Integrated Medical Research | Virginia Beach Virginia, United States, 23454Northwest Clinical Research Center | Bellevue Washington, United States, 98007Seattle Women's: Health, Research, Gynecology | Seattle Washington, United States, 98105Clinical Investigation Specialist, Inc. | Kenosha Wisconsin, United States, 53144
Study Documents (Full Text)
Documents provided by Pfizer: Study Protocol  June 1, 2021Documents provided by Pfizer: Statistical Analysis Plan  September 14, 2021