Clinical trial NCT04408794: Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
Official title: A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Migraine
Keywords: migraine, headache, intranasal
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-29
Enrollment: 974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine.

\* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.


Eligibility criteria: Inclusion Criteria:

* 2-8 moderate to severe migraines/month within the last 3 months
* Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
* Migraine attacks, on average, lasting about 4-72 hours if untreated
* Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
* Ability to distinguish migraine attacks from tension/cluster headaches
* Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria

Exclusion Criteria:

* History of human immunodeficiency virus disease
* History of basilar or hemiplegic migraine
* Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
* History of nasal surgery in the 6 months preceding the screening visit
* History of gallstones or cholecystectomy
* History of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etcetera), or other disease or condition (for example, chronic pancreatitis, ulcerative colitis, etcetera) that causes malabsorption.
* Body mass index ≥ 33
* Hemoglobin A1c ≥6.5%

Primary outcomes:
measure: Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation
timeFrame: From study drug dosing up to the end of the study (up to 52 weeks)
measure: Number Of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: From study drug dosing up to the end of the study (up to 52 weeks)
Secondary outcomes:
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: 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: 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: Wr-Pri, Llc
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
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: 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: 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: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Tampa
country: United States
facility: Meridien Research
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: Anderson
country: United States
facility: Community Hospital of Anderson and Madison County Inc
state: Indiana
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: Chalmette
country: United States
facility: Crescent City Headache and Neurology Center
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: 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: Lebanon
country: United States
facility: Dartmouth-Hitchcock Heater Road
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
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: 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: Wilmington
country: United States
facility: Wilmington Health, PLLC
state: North Carolina
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: 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: 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: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
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: 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: