Randomized Trial in Adult Participants With Acute Migraines
NCT ID: NCT04571060
Last Updated: 2023-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1978 participants
INTERVENTIONAL
2020-10-27
2021-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
Placebo
One dose of matching placebo
Interventions
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Zavegepant
One dose of zavegepant
Placebo
One dose of matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Locations
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Medical Affiliated Research Center
Huntsville, Alabama, United States
Coastal Clinical Research, LLC, An AMR Co.
Mobile, Alabama, United States
MD First Research
Chandler, Arizona, United States
Tucson Neuroscience Research
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Axiom Research, LLC
Colton, California, United States
Pharmacology Research Institute
Encino, California, United States
eStudySite
La Mesa, California, United States
Synergy San Diego
Lemon Grove, California, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Clinical Research Institute
Los Angeles, California, United States
Wr-Pri, Llc
Newport Beach, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
CT Clinical Research
Cromwell, Connecticut, United States
Ki Health Partners, LLC dba New England Institute for Clinical Research
Stamford, Connecticut, United States
Neurology Offices of South Florida
Boca Raton, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Meridien Research
Lake Mary, Florida, United States
AppleMed Research Group, LLC
Miami, Florida, United States
The Neurology Research Group
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Complete Health Research
Ormond Beach, Florida, United States
Ideal Clinical Research
Pembroke Pines, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Clin-Med Research & Development, LLC
South Miami, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
JSV Clinical Research Study, Inc.
Tampa, Florida, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Northwest Clinical Trials Inc.
Boise, Idaho, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Collective Medical Research
Prairie Village, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Crescent City Headache and Neurology Center
Chalmette, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Community Clinical Research Network
Marlborough, Massachusetts, United States
Boston Neuro Research Center
South Dartmouth, Massachusetts, United States
Medvadis Research Corporation
Waltham, Massachusetts, United States
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Clinvest Research LLC
Springfield, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Dent Neurosciences Research Center
Amherst, New York, United States
Regional Clinical Research
Endwell, New York, United States
Central New York Clinical Research
Manlius, New York, United States
Fieve Clinical Research, Inc
New York, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Montefiore Medical Center: Headache Center
The Bronx, New York, United States
Headache Wellness Center
Greensboro, North Carolina, United States
PharmQuest LLC
Greensboro, North Carolina, United States
PMG of Raleigh, LLC
Raleigh, North Carolina, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
Hometown Urgent Care & Research/ Wellnow
Cincinnati, Ohio, United States
Hometown Urgent Care and Research
Columbus, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
The Orthopedic Foundation
New Albany, Ohio, United States
OK Clinical Research LLC
Edmond, Oklahoma, United States
Tekton Research, Inc.
Yukon, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Union, Pennsylvania, United States
MD First Research
Lancaster, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Donald J. Garcia, Jr, MD, PA
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Red Star Research LLC
Lake Jackson, Texas, United States
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Alpine Medical Group
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
Clinical Investigation Specialist, Inc.
Kenosha, Wisconsin, United States
Countries
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References
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Lipton RB, Croop R, Stock DA, Madonia J, Forshaw M, Lovegren M, Mosher L, Coric V, Goadsby PJ. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023 Mar;22(3):209-217. doi: 10.1016/S1474-4422(22)00517-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C5301001
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3500-301
Identifier Type: -
Identifier Source: org_study_id
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