Open Label Safety Study in Acute Treatment of Migraine

Migraine, With or Without Aura Clinical Trial

Official title:

A Multicenter, Open Label Long-Term Safety Study of BHV-3000 in the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266588
• Other study ID #: BHV3000-201
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 30, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: February 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3019
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Subjects with 2-8 moderate to severe migraines/month

• Age of onset of migraines prior to 50 years of age

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

• Ability to distinguish migraine attacks from tension/cluster headaches

• Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria

Key Exclusion Criteria:

• History of basilar migraine or hemiplegic migraine

• History of HIV disease

• History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia.

• Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening

• History of gastric or small intestinal surgery or has a disease that causes malabsorption

• BMI = 30

• HbA1c = 6.5%

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine, With or Without Aura

Intervention

Drug:
• Rimegepant
75 mg oral tablet

Locations

Country	Name	City	State
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	PMG Research of McFrland Clinic	Ames	Iowa
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Michigan Head Pain and Neurological Institute	Ann Arbor	Michigan
United States	Radiant Research, Inc.	Atlanta	Georgia
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	FutureSearch Trials of Neurology, LP	Austin	Texas
United States	Tekton Research- Austin	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Hassman Research Institute, LLC	Berlin	New Jersey
United States	United Medical Associates	Binghamton	New York
United States	Central Research Associates, Inc	Birmingham	Alabama
United States	Boston Clinical Trials, Inc.	Boston	Massachusetts
United States	PMG Research of Bristol, LLC	Bristol	Tennessee
United States	Montefiore Heachache Center	Bronx	New York
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Christie Clinic, LLC	Champaign	Illinois
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Radiant Research, Inc.	Columbus	Ohio
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	FutureSearch Trials of Neurology, LP	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Neurology Diagnostics, Inc.	Dayton	Ohio
United States	Clinical Trials of the Rockies	Denver	Colorado
United States	Aventiv Research, Inc.	Dublin	Ohio
United States	Pharmacology Research Institute	Encino	California
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	NECCR Primacare Research, LLC	Fall River	Massachusetts
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	Thunderbird Internal Medicine / Radiant Research, Inc	Glendale	Arizona
United States	PharmQuest, LLC	Greensboro	North Carolina
United States	AGA Clinical Trials	Hialeah	Florida
United States	Texas Center for Drug Development	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Radiant Research, Inc.	Jamaica	New York
United States	The Center for Pharmaceutical Research	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	Clinical Research Consortium- Las Vegas	Las Vegas	Nevada
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	PCP for Life	Magnolia	Texas
United States	Central New York Clinical Research	Manlius	New York
United States	Milford Emergency Associates, Inc.	Marlborough	Massachusetts
United States	Clinical Neuroscience Solutions, Inc	Memphis	Tennessee
United States	Research Across America - Mesquite	Mesquite	Texas
United States	Benchmark Research	Metairie	Louisiana
United States	MedPharmics, LLC	Metairie	Louisiana
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Fieve Clinical Research	New York	New York
United States	Pharmacology Research Institute	Newport Beach	California
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Meridian Clinical Research -Norfolk	Norfolk	Nebraska
United States	Pacific Research Partners LLC	Oakland	California
United States	Renstar Medical Research	Ocala	Florida
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Compass Research, LLC	Orlando	Florida
United States	Ormond Medical Arts Pharmaceutical Research	Ormond Beach	Florida
United States	National Research Institute	Panorama City	California
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Doctors of Internal Medicine, LTD / Radiant Research Inc.	Plano	Texas
United States	Clinical Research Insitute	Plymouth	Minnesota
United States	Summit Research Network (Oregon), Inc.	Portland	Oregon
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Woodland Research Northwest, LLC	Rogers	Arkansas
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Oregon Center for Clinical Investigations, Inc	Salem	Oregon
United States	J.Lewis Research Inc / Foothill Family Clinic South	Salt Lake City	Utah
United States	Optimus Medical Group	San Francisco	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Savannah Neurology Specialists	Savannah	Georgia
United States	Fieve Clinical Research	Scranton	Pennsylvania
United States	Seattle Women's:Health, Research & Gynecology	Seattle	Washington
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Meridien Research	Tampa	Florida
United States	Clinical Research Consortium Arizona	Tempe	Arizona
United States	Neurological Physicians of Arizona	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	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	Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Primary	Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period	Clinically significant laboratory abnormalities were defined as Grade 3 to 4 on-treatment laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for Glucose, LDL-Cholesterol, Uric Acid, and Urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the on-treatment period to be included for a given parameter.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks
Secondary	Percentage of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin > 2 x ULN During the Treatment Period	Elevations of on-treatment AST or ALT > 3 x ULN concurrent with total bilirubin > 2 x ULN were defined as elevations on the same collection date.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Secondary	Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation patient administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Hepatic AEs were defined as all on-treatment PTs under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those PTs in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks