Clinical trial NCT04571060: Randomized Trial in Adult Participants With Acute Migraines
Official title: Double-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Acute Migraine
Phonophobia
Photophobia
Nausea
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-09-30
Enrollment: 1978
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or severe migraine.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: Percentage of Participants With Pain Relief at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose
timeFrame: From 2 to 24 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose
timeFrame: From 2 to 48 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose
timeFrame: From 2 to 24 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose
timeFrame: From 2 to 48 hours post-dose
measure: Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Pain Relief at 60 Minutes Post-dose
timeFrame: 60 minutes post-dose
measure: Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose
timeFrame: 60 minutes post-dose
measure: Percentage of Participants With Pain Relief at 30 Minutes Post-dose
timeFrame: 30 minutes post-dose
measure: Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose
timeFrame: 30 minutes post-dose
measure: Percentage of Participants With Pain Relief at 15 Minutes Post-dose
timeFrame: 15 minutes post-dose
measure: Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose
timeFrame: 15 minutes post-dose
measure: Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
timeFrame: Through 24 hours post-dose
measure: Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
timeFrame: From 2 hours to 48 hours post-dose
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, LLC, An AMR Co.
state: Alabama
city: Chandler
country: United States
facility: MD First Research
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Colton
country: United States
facility: Axiom Research, LLC
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: Newport Beach
country: United States
facility: Wr-Pri, Llc
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners, LLC dba New England Institute for Clinical Research
state: Connecticut
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Lake Mary
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group, LLC
state: Florida
city: Miami
country: United States
facility: The Neurology Research Group
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Complete Health Research
state: Florida
city: Pembroke Pines
country: United States
facility: Ideal Clinical Research
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: South Miami
country: United States
facility: Clin-Med Research & Development, LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: JSV Clinical Research Study, Inc.
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials Inc.
state: Idaho
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Prairie Village
country: United States
facility: Collective Medical Research
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Chalmette
country: United States
facility: Crescent City Headache and Neurology Center
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Marlborough
country: United States
facility: Community Clinical Research Network
state: Massachusetts
city: South Dartmouth
country: United States
facility: Boston Neuro Research Center
state: Massachusetts
city: Waltham
country: United States
facility: Medvadis Research Corporation
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache and Neurological Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center: Headache Center
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: New York
country: United States
facility: Fieve Clinical Research, Inc
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG of Raleigh, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health, PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: Hometown Urgent Care & Research/ Wellnow
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: New Albany
country: United States
facility: The Orthopedic Foundation
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research LLC
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research, Inc.
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Union
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Lancaster
country: United States
facility: MD First Research
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Donald J. Garcia, Jr, MD, PA
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. (CTT)
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Alpine Medical Group
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialist, Inc.
state: Wisconsin
Study officials:
References: