A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

Migraine Clinical Trial

Official title:

A Phase 2/3 Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04804033
• Other study ID #: BHV3500-302
• Secondary ID: C5301006
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 26, 2021
• Est. completion date: March 21, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 542
• Est. completion date: March 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of

Headache Disorders, 3rd Edition, including the following:

1. Age of onset of migraines prior to 50 years of age

2. Migraine attacks, on average, lasting 4 - 72 hours if untreated

3. Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit

4. Eight or more migraine days during the Observation Period

5. 15 or more headache days during the Observation Period

6. One or more non-headache days during the Observation Period

7. Ability to distinguish migraine attacks from tension/cluster headaches

8. Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.

Exclusion Criteria:

1. Subject with a history of HIV disease

2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects 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 subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).

4. Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit.

5. Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy.

6. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.

7. Body mass index > 33 kg/m2

8. History of gallstones or cholecystectomy.

9. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or 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 (AE) or interfere with assessments of safety or efficacy during the course of the trial

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• BHV-3500 (zavegepant)
BHV-3500 (zavegepant) softgel capsule.
• Placebo
Matching placebo softgel capsule.

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Dent Neurosciences Research Center, Inc.	Amherst	New York
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Accellacare (Administrative Only)	Bristol	Tennessee
United States	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee
United States	Montefiore Medical Center	Bronx	New York
United States	Hope Clinical Research	Canoga Park	California
United States	Crescent City Headache and Neurology Center	Chalmette	Louisiana
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Wellnow Urgent Care	Cincinnati	Ohio
United States	Axiom Research, Llc	Colton	California
United States	Hometown Urgent Care and Research	Columbus	Ohio
United States	Wellnow Urgent Care and Research	Columbus	Ohio
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	WellNow Urgent Care and Research	Dayton	Ohio
United States	CenExel iResearch, LLC	Decatur	Georgia
United States	iResearch Atlanta LLC	Decatur	Georgia
United States	Complete Health Research	Edgewater	Florida
United States	Alliance for Multispecialty Reseach, LLC	El Dorado	Kansas
United States	Wr-Pri, Llc	Encino	California
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	MediSphere Medical Research Center, LLC.	Evansville	Indiana
United States	Neurology Center of New England P.C.	Foxboro	Massachusetts
United States	KCA Neurology, PLLC	Franklin	Tennessee
United States	North Texas Institute of Neurology and Headache	Frisco	Texas
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Headache Wellness Center	Greensboro	North Carolina
United States	Clinical Investigation Specialists, Inc	Gurnee	Illinois
United States	Clinical Investigation Specialists, Inc.	Gurnee	Illinois
United States	CMR of Greater New Haven, LLC	Hamden	Connecticut
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Alliance for Multispecialty Reseach, LLC	Kansas City	Missouri
United States	eStudySite	La Mesa	California
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Red Star Research. LLC	Lake Jackson	Texas
United States	FMC Science	Lampasas	Texas
United States	Radiance Clinical Research	Lampasas	Texas
United States	Excel Clinical research	Las Vegas	Nevada
United States	Wr-Crcn, Llc	Las Vegas	Nevada
United States	Synergy San Diego	Lemon Grove	California
United States	The Research Group of Lexington, Llc	Lexington	Kentucky
United States	The Research Group of Lexington, Llc.	Lexington	Kentucky
United States	Collaborative Neuroscience Research, LLC.	Long Beach	California
United States	Clinical Research Institute	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Central New York Clinical Research	Manlius	New York
United States	Community Clinical Research Network Inc	Marlborough	Massachusetts
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	AppleMed Research Group, LLC	Miami	Florida
United States	AppleMed Research Group, LLC	Miami	Florida
United States	Brainstorm Research	Miami	Florida
United States	The Neurology Research Group	Miami	Florida
United States	Alliance for Multispecialty Research, LLC.	New Orleans	Louisiana
United States	DelRicht Research	New Orleans	Louisiana
United States	Fieve Clinical Research, Inc	New York	New York
United States	New York Neurology Associates	New York	New York
United States	Wr-Pri, Llc	Newport Beach	California
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Meridian Clinical Research, LLC	Norfolk	Virginia
United States	Neuro-Behavioral Clinical Research, Inc.	North Canton	Ohio
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Complete Health Research	Ormond Beach	Florida
United States	Collevtive Medical Research	Overland Park	Kansas
United States	Kansas Institute of Research	Overland Park	Kansas
United States	Ideal Clinical Research	Pembroke Pines	Florida
United States	Clinical Research Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Xenoscience, Inc	Phoenix	Arizona
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	North Suffolk Neurology, PC	Port Jefferson Station	New York
United States	Summit Headlands LLC, dba Summit Research	Portland	Oregon
United States	Accellacare	Raleigh	North Carolina
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Romedica LLC	Rochester	Michigan
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Accel Research Sites Network - St. Petersburg Clinical Research Unit	Saint Petersburg	Florida
United States	Wasatch Clinical Research , LLC(Administrative Location)	Salt Lake City	Utah
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Seattle Clinical Research Center	Seattle	Washington
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	Carolina Research Center, Inc.	Shelby	North Carolina
United States	California Neuroscience Research Medical Group, inc.	Sherman Oaks	California
United States	Meridian Clinical Research, LLC	Sioux City	Iowa
United States	Clin-Med Research & Development LLC	South Miami	Florida
United States	Clinvest Research, LLC	Springfield	Missouri
United States	Clinvest Research, LLC	Springfield	Missouri
United States	Ki Health Partners, LLc, dba New England Institute for Clinical Research	Stamford	Connecticut
United States	ForCare Clinical Research	Tampa	Florida
United States	JSV Clinical Research Study Inc	Tampa	Florida
United States	DM Clinical Research	Tomball	Texas
United States	WellNow Urgent Care and Research	Troy	Ohio
United States	Tucson Neuroscience Research	Tucson	Arizona
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Reading Hospital Clinical Trials Office	West Reading	Pennsylvania
United States	Tower Health Medical Group - Neurology	West Reading	Pennsylvania
United States	Upstate Clinical Research Associates, LLC	Williamsville	New York
United States	Accellacare	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of zavegepant compared to placebo as a preventive treatment for migraine	Measured by the mean reduction from baseline (i.e., Observation Phase) in the number of migraine days per month over the entire Double-blind Treatment Phase.	Number of migraine during weeks 1 to 12
Secondary	Efficacy of zavegepant compared to placebo with the number of subjects that had a = 50% reduction from Observational Phase.	Measured by the number of moderate to severe migraine days per month over the entire double-blind treatment phase.	Number of migraine days during weeks 1 to 12
Secondary	Efficacy of zavegepant to placebo on mean reduction from Observational Phase.	Measured by the number of migraine days in the last 4 weeks of the Double-Blind Treatment Phase.	Number of migraine days during per month during weeks 9 to 12
Secondary	Efficacy of zavegepant to placebo on mean reduction from Observational Phase.	Measured by the number of migraine days per month in the first 4 weeks of the Double-Blind Treatment Phase.	Number of migraine days per month during weeks 1 to 4
Secondary	Efficacy of zavegepant to placebo in the mean number of acute migraine specific medication days per month.	Measured by the number of acute migraine specific medication days over the entire Double-Blind Treatment Phase.	Number of migraine days per month during weeks 1 to 12
Secondary	Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase.	The change from baseline is calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline.	Week 12 of the double-blind treatment phase.
Secondary	Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase.	The change from baseline is calculated as the MIDAS total score at Week 12 of the DBT phase minus the MIDAS total score at baseline.	Week 12 of the double-blind treatment phase.
Secondary	Evaluate the safety and tolerability of zavegepant.	This will be evaluated by the number of participants with treatment related adverse events by severity measured as mild, moderate, or severe.	From Baseline through Week 12
Secondary	The frequency of ALT or AST elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN in subjects treated with zavegepent during the double-blind and open label phases.		From Baseline through Week 12
Secondary	The frequency of hepatic related adverse events.	Measured by discontinuations in subjects treated with zavegepant due to elevated Liver Function Tests during the double-blind and open label phases	From Baseline through Week 12

External Links

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