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Open Label Safety Study in Acute Treatment of Migraine

Primary Purpose

Migraine, With or Without Aura

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rimegepant
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine, With or Without Aura

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Central Research Associates, Inc
  • Coastal Clinical Research, Inc.
  • Thunderbird Internal Medicine / Radiant Research, Inc
  • Neurological Physicians of Arizona
  • Clinical Research Consortium Arizona
  • Woodland International Research Group, LLC
  • Woodland Research Northwest, LLC
  • Pharmacology Research Institute
  • eStudySite
  • Collaborative Neuroscience Network, LLC
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Pacific Research Partners LLC
  • National Research Institute
  • Optimus Medical Group
  • California Medical Clinic for Headache
  • California Neuroscience Research Medical Group, Inc.
  • Diablo Clinical Research, Inc
  • Clinical Trials of the Rockies
  • AGA Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Multi-Specialty Research Associates, Inc
  • Renstar Medical Research
  • Clinical Neuroscience Solutions, Inc
  • Compass Research, LLC
  • Ormond Medical Arts Pharmaceutical Research
  • Meridien Research
  • Radiant Research, Inc.
  • Meridian Clinical Research
  • Savannah Neurology Specialists
  • Christie Clinic, LLC
  • PMG Research of McFrland Clinic
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Benchmark Research
  • MedPharmics, LLC
  • New Orleans Center for Clinical Research
  • Boston Clinical Trials, Inc.
  • NECCR Primacare Research, LLC
  • Milford Emergency Associates, Inc.
  • Michigan Head Pain and Neurological Institute
  • Clinical Research Institute, Inc.
  • Clinical Research Insitute
  • The Center for Pharmaceutical Research
  • Sundance Clinical Research, LLC
  • Meridian Clinical Research -Norfolk
  • Meridian Clinical Research, LLC
  • Clinical Research Consortium- Las Vegas
  • Hassman Research Institute, LLC
  • Albuquerque Neuroscience, Inc.
  • United Medical Associates
  • Montefiore Heachache Center
  • SPRI Clinical Trials, LLC
  • Regional Clinical Research, Inc.
  • Radiant Research, Inc.
  • Central New York Clinical Research
  • Fieve Clinical Research
  • Rochester Clinical Research, Inc
  • PMG Research of Charlotte, LLC
  • PharmQuest, LLC
  • PMG Research of Raleigh, LLC
  • Wake Research Associates, LLC
  • PMG Research of Wilmington, LLC
  • CTI Clinical Research Center
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Midwest Clinical Research Center
  • Neurology Diagnostics, Inc.
  • Aventiv Research, Inc.
  • Summit Research Network (Oregon), Inc.
  • Oregon Center for Clinical Investigations, Inc
  • Clinical Research of Philadelphia, LLC
  • Fieve Clinical Research
  • Preferred Primary Care Physicians
  • Omega Medical Research
  • Radiant Research, Inc.
  • Coastal Carolina Research Center
  • Meridian Clinical Research
  • PMG Research of Bristol, LLC
  • Clinical Neuroscience Solutions, Inc
  • Clinical Research Associates, Inc.
  • FutureSearch Trials of Neurology, LP
  • Tekton Research- Austin
  • FutureSearch Trials of Neurology, LP
  • Ventavia Research Group, LLC
  • Texas Center for Drug Development
  • Red Star Research, LLC
  • FMC Science
  • PCP for Life
  • Research Across America - Mesquite
  • Doctors of Internal Medicine, LTD / Radiant Research Inc.
  • DM Clinical Research
  • J.Lewis Research Inc / Foothill Family Clinic South
  • Tidewater Integrated Medical Research
  • Northwest Clinical Research Center
  • Seattle Women's:Health, Research & Gynecology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rimegepant

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 23, 2017
Last Updated
February 14, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03266588
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, With or Without Aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3019 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rimegepant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Other Intervention Name(s)
BHV-3000
Intervention Description
75 mg oral tablet
Primary Outcome Measure Information:
Title
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Description
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.
Time Frame
PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Title
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Description
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.
Time Frame
PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Title
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period
Description
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.
Time Frame
PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Facility Information:
Facility Name
Central Research Associates, Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Thunderbird Internal Medicine / Radiant Research, Inc
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Neurological Physicians of Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Clinical Research Consortium Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Woodland International Research Group, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pacific Research Partners LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
National Research Institute
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Optimus Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Diablo Clinical Research, Inc
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Trials of the Rockies
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
AGA Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Multi-Specialty Research Associates, Inc
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Radiant Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Savannah Neurology Specialists
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Christie Clinic, LLC
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
PMG Research of McFrland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Benchmark Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
MedPharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Boston Clinical Trials, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
NECCR Primacare Research, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Milford Emergency Associates, Inc.
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research Insitute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Meridian Clinical Research -Norfolk
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Clinical Research Consortium- Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Hassman Research Institute, LLC
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
United Medical Associates
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Montefiore Heachache Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SPRI Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Radiant Research, Inc.
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Central New York Clinical Research
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Fieve Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10168
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
PharmQuest, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Radiant Research, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Radiant Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Neurology Diagnostics, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Aventiv Research, Inc.
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Summit Research Network (Oregon), Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Fieve Clinical Research
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Radiant Research, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Meridian Clinical Research
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
PMG Research of Bristol, LLC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
FutureSearch Trials of Neurology, LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Tekton Research- Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
FutureSearch Trials of Neurology, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Center for Drug Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Red Star Research, LLC
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
FMC Science
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
PCP for Life
City
Magnolia
State/Province
Texas
ZIP/Postal Code
77355
Country
United States
Facility Name
Research Across America - Mesquite
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Doctors of Internal Medicine, LTD / Radiant Research Inc.
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J.Lewis Research Inc / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Seattle Women's:Health, Research & Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35038983
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.
Results Reference
derived
PubMed Identifier
34455556
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.
Results Reference
derived
PubMed Identifier
31932515
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. Erratum In: Neurology. 2020 May 19;94(20):900.
Results Reference
derived

Learn more about this trial

Open Label Safety Study in Acute Treatment of Migraine

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