Clinical trial NCT03266588: Open Label Safety Study in Acute Treatment of Migraine
Official title: A Multicenter, Open Label Long-Term Safety Study of BHV-3000 in the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Migraine, With or Without Aura
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-08-30
Enrollment: 3019
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 safety and tolerability of BHV-3000 (rimegepant).


Eligibility criteria: 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%

Primary outcomes:
measure: Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
timeFrame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
measure: Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
timeFrame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks
Secondary outcomes:
measure: 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
timeFrame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
measure: Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period
timeFrame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Glendale
country: United States
facility: Thunderbird Internal Medicine / Radiant Research, Inc
state: Arizona
city: Tempe
country: United States
facility: Neurological Physicians of Arizona
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Consortium Arizona
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group, LLC
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC
state: Arkansas
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: La Mesa
country: United States
facility: eStudySite
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: Oakland
country: United States
facility: Pacific Research Partners LLC
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: California Medical Clinic for Headache
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc
state: California
city: Denver
country: United States
facility: Clinical Trials of the Rockies
state: Colorado
city: Hialeah
country: United States
facility: AGA Clinical Trials
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: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
facility: Radiant Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Savannah
country: United States
facility: Savannah Neurology Specialists
state: Georgia
city: Champaign
country: United States
facility: Christie Clinic, LLC
state: Illinois
city: Ames
country: United States
facility: PMG Research of McFrland Clinic
state: Iowa
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials, Inc.
state: Massachusetts
city: Fall River
country: United States
facility: NECCR Primacare Research, LLC
state: Massachusetts
city: Marlborough
country: United States
facility: Milford Emergency Associates, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Insitute
state: Minnesota
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research -Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium- Las Vegas
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Bronx
country: United States
facility: Montefiore Heachache Center
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Jamaica
country: United States
facility: Radiant Research, Inc.
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
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research, Inc.
state: Ohio
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
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Scranton
country: United States
facility: Fieve Clinical Research
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc.
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: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology, LP
state: Texas
city: Austin
country: United States
facility: Tekton Research- Austin
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Neurology, LP
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: Magnolia
country: United States
facility: PCP for Life
state: Texas
city: Mesquite
country: United States
facility: Research Across America - Mesquite
state: Texas
city: Plano
country: United States
facility: Doctors of Internal Medicine, LTD / Radiant Research Inc.
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: J.Lewis Research Inc / Foothill Family Clinic South
state: Utah
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
Study officials:
References:
citation: Johnston K, Harris L, Powell L, Popoff E, Coric V, L'Italien G, Schreiber CP. Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201). J Headache Pain. 2022 Jan 17;23(1):10. doi: 10.1186/s10194-021-01378-5.
citation: Johnston KM, L'Italien G, Popoff E, Powell L, Croop R, Thiry A, Harris L, Coric V, Lipton RB. Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant. Adv Ther. 2021 Oct;38(10):5209-5220. doi: 10.1007/s12325-021-01897-2. Epub 2021 Aug 29.
citation: Mullin K, Kudrow D, Croop R, Lovegren M, Conway CM, Coric V, Lipton RB. Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology. 2020 May 19;94(20):e2121-e2125. doi: 10.1212/WNL.0000000000008944. Epub 2020 Jan 13.