Clinical trial NCT03872453: Acute Treatment Trial in Adult Subjects With Migraines
Official title: Phase II/III: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Migraine
Keywords: Acute Migraine
phonophobia
photophobia
nausea
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 2154
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 the study is to evaluate the safety and efficacy of three different intranasal dose levels of zavegepant (BHV-3500), relative to placebo, in the acute treatment of moderate to severe migraine.


Eligibility criteria: Inclusion Criteria:

Key Inclusion Criteria:

1. Participants have 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 throughout 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 throughout 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.

Exclusion Criteria:

Key Exclusion Criteria:

1. Participant with a history of basilar migraine or hemiplegic migraine.
2. Participant with a history of human immunodeficiency virus (HIV) disease.
3. 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, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
4. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled).
5. Participant has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (for example, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
6. Participant has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.), or has disease that causes malabsorption.
7. The participant has a history of current or evidence of any significant and/ or unstable medical conditions (for example, history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the Investigator's opinion, would expose them to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial.
8. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM-V) criteria for any significant substance use disorder within the past 12 months from the date of the Screening Visit.
9. History of nasal surgery in the 6 months preceding the Screening Visit.
10. Participation in any other investigational clinical trial while participating in this clinical trial.

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 Rescue Medication Use Within 24 Hours Post-dose
timeFrame: Through 24 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 Freedom From Phonophobia 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 Sustained Pain Relief From 2 to 24 Hours Post-dose
timeFrame: From 2 hours up to 24 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
timeFrame: From 2 hours up to 24 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 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 up to 48 hours post-dose
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
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: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Panorama City
country: United States
facility: National Research Institute
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Denver
country: United States
facility: Denver Neurological Research, LLC
state: Colorado
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: Hallandale Beach
country: United States
facility: MD Clinical
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: Miami
country: United States
facility: AGA Clinical Trials
state: Florida
city: Miami
country: United States
facility: Qps Mra, Llc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Wauconda
country: United States
facility: Family Medicine Specialists/CIS
state: Illinois
city: Prairie Village
country: United States
facility: Phoenix Medical Research
state: Kansas
city: Chalmette
country: United States
facility: Crescent City Headache and Neurology Center, LLC
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
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: North Attleboro
country: United States
facility: Regeneris Medical
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Biloxi
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research, LLC
state: Missouri
city: North Kansas City
country: United States
facility: Meritas Health Neurology
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: QPS Bio-Kinetic Clinical Applications, LLC
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
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: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research 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 and Research
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: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
state: Oregon
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research
state: South Dakota
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research/New Orleans Center for Clinical Research/Volunteer Research
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions DBA CNS Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: Magnolia
country: United States
facility: Advanced Pharmaceutical Development Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research
state: Texas
city: Tomball
country: United States
facility: Dynamed Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
Study officials:
References: