Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Who is this study for? Patients with Migraine
What treatments are being studied? Rimegepant / BHV3000
Status: Recruiting
Location: See all (120) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• History of migraine (with or without aura) for ≥ 6 months before Screening.

• History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.

• 1 or more migraine days requiring treatment during the Observation Phase.

• Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.

• Ability to distinguish between migraine and other types of headaches.

• Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg.

• Adequate venous access for blood sampling.

• Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).

Locations
United States
Arizona
Perseverance Research Center, LLC
RECRUITING
Scottsdale
Physicians Research Group
ACTIVE_NOT_RECRUITING
Tempe
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
ProScience Research Group
RECRUITING
Culver City
Neuro-Pain Medical Center
RECRUITING
Fresno
University of California San Diego, Altman Clinical and Translational Research Institute Clinic
RECRUITING
La Jolla
Adult & Child Neurology Medical Associates
RECRUITING
Long Beach
Memorialcare Miller Children's & Women's Hospital Long Beach
RECRUITING
Long Beach
Velocity Clinical Research - North Hollywood
RECRUITING
North Hollywood
The Neurology Group
RECRUITING
Pomona
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
RECRUITING
Sacramento
University of California, Davis Clinical and Translational Science Center Clinical Research Center
RECRUITING
Sacramento
University of California, Davis Midtown Clinic
RECRUITING
Sacramento
Velocity Clinical Research- Banning
RECRUITING
San Bernardino
Pacific Clinical Research Management Group LLC
RECRUITING
Upland
Sunwise Clinical Research
RECRUITING
Walnut Creek
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Children's Hospital Colorado- Investigational Drug Services
RECRUITING
Aurora
Colorado Springs Neurological Associates
RECRUITING
Colorado Springs
Boeson Research GJT
TERMINATED
Grand Junction
Boeson Research GJT
TERMINATED
Grand Junction
Dinosaur Pediatrics
TERMINATED
Grand Junction
Connecticut
CT Clinical Research
RECRUITING
Cromwell
Ki Health Partners, LLc, dba New England Institute for Clinical Research
RECRUITING
Stamford
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Florida
AppleMed Research Group, LLC
RECRUITING
Miami
Brainstorm Research
RECRUITING
Miami
Medical Research Center of Miami II, Inc
ACTIVE_NOT_RECRUITING
Miami
South Florida Research Phase I-IV, Inc
RECRUITING
Miami Springs
Physicians Group Services, PA d/b/a Coastal Health Research
RECRUITING
Orange Park
Clinical Associates of Orlando, LLC
RECRUITING
Orlando
ForCare Clinical Research
RECRUITING
Tampa
Premiere Research Institute at Palm Beach Neurology
ACTIVE_NOT_RECRUITING
West Palm Beach
Georgia
Childrens Healthcare of Atlanta
RECRUITING
Atlanta
Rare Disease Research LLC
ACTIVE_NOT_RECRUITING
Atlanta
Pivotal Clinical Research & Associates, LLC
RECRUITING
Brunswick
CenExel iResearch, LLC
RECRUITING
Decatur
Iowa
Integrated Clinical Trial Services
RECRUITING
West Des Moines
Illinois
Chicago Headache Center & Research Institute
RECRUITING
Chicago
Indiana
Options Research Group, LLC
RECRUITING
Westfield
Kentucky
University of Kentucky Hospital
ACTIVE_NOT_RECRUITING
Lexington
Louisiana
Ochsner Clinic Foundation
TERMINATED
New Orleans
Massachusetts
MedVadis Research Corporation
ACTIVE_NOT_RECRUITING
Waltham
Michigan
Michigan Head Pain and Neurological Institute
RECRUITING
Ann Arbor
Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
RECRUITING
Grand Rapids
Corewell Health, Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Wellnow Urgent Care and Research
TERMINATED
Kalamazoo
Beaumont Hospital, Royal Oak Campus
RECRUITING
Royal Oak
Missouri
Sharlin Health Neuroscience Research Center
RECRUITING
Ozark
Clinvest Research, LLC
ACTIVE_NOT_RECRUITING
Springfield
Montana
Boeson Research
RECRUITING
Great Falls
Heart & Hands Midwifery
RECRUITING
Kalispell
Blue Moose Pediatrics
RECRUITING
Missoula
Boeson Research
RECRUITING
Missoula
Boeson Research Laboratory
RECRUITING
Missoula
North Carolina
Headache Wellness Center, PC
RECRUITING
Greensboro
Nebraska
Alivation Research, LLC
TERMINATED
Lincoln
Children's Hospital & Medical Center
RECRUITING
Omaha
New Jersey
HMH Jersey Shore University Medical Center
NOT_YET_RECRUITING
Neptune City
New York
Dent Neurosciences Research Center
RECRUITING
Amherst
True North Neurology
RECRUITING
Commack
Columbia University Irving Medical Center
RECRUITING
New York
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
RECRUITING
New York
Mount Sinai Hospital - Pharmacy Department
ACTIVE_NOT_RECRUITING
New York
New York Neurology Associates
RECRUITING
New York
The Neurological Institute of New York
RECRUITING
New York
North Suffolk Neurology
ACTIVE_NOT_RECRUITING
Port Jefferson Station
Ohio
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Velocity Clinical Research - Cincinnati
RECRUITING
Cincinnati
WellNow Urgent Care and Research
ACTIVE_NOT_RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Wellnow Urgent Care and Research
ACTIVE_NOT_RECRUITING
Dayton
Oklahoma
IPS Research Company
ACTIVE_NOT_RECRUITING
Oklahoma City
Oregon
Velocity Clinical Research, Grants Pass
ACTIVE_NOT_RECRUITING
Grants Pass
Providence Brain & Spine Institute-research coordinator's office
RECRUITING
Portland
Providence Health & Services Investigational Drug Services Westside
RECRUITING
Portland
Providence St. Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Children's Hospital of Philadelphia
ACTIVE_NOT_RECRUITING
Philadelphia
Clario
RECRUITING
Philadelphia
Rhode Island
Velocity Clinical Research-Providence
RECRUITING
East Greenwich
South Carolina
Velocity Clinical Research- Greenville
ACTIVE_NOT_RECRUITING
Greenville
Premier Neurology
ACTIVE_NOT_RECRUITING
Greer
Tennessee
Novaceut Clinical Research
ACTIVE_NOT_RECRUITING
Clarksville
Le Bonheur Children's Hospital
RECRUITING
Memphis
Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
RECRUITING
Memphis
Le Bonheur Childrens Hospital - Outpatient Building
RECRUITING
Memphis
Access Clinical Trials, Inc.
TERMINATED
Nashville
Texas
Child Neurology Consultants of Austin - Central Austin
RECRUITING
Austin
Child Neurology Consultants of Austin - South Austin
RECRUITING
Austin
Dell Children's Medical Center
RECRUITING
Austin
Houston Clinical Trials, LLC
RECRUITING
Bellaire
Cedar Health Research
RECRUITING
Dallas
Infinite Research Group, LLC
RECRUITING
Dallas
ANESC Research
RECRUITING
El Paso
North Texas Institute of Neurology and Headache
ACTIVE_NOT_RECRUITING
Frisco
Houston Clinical Research,LLC.
TERMINATED
Houston
NeuroCare Plus
RECRUITING
Houston
Pain and Headache Centers of Texas
RECRUITING
Houston
SCLA Management
RECRUITING
Houston
Trio Clinical Trials, LLC.
ACTIVE_NOT_RECRUITING
Houston
AIM Trials, LLC
RECRUITING
Plano
Utah
JBR Clinical Research
RECRUITING
Salt Lake City
Wasatch Clinical Research , LLC(Administrative Location)
RECRUITING
Salt Lake City
Virginia
Children's Hospital of The King's Daughters
RECRUITING
Norfolk
Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology
RECRUITING
Norfolk
National Clinical Research, Inc.
TERMINATED
Richmond
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Seattle Children's Hospital
RECRUITING
Seattle
Seattle Children's Hospital Investigational Drug Services
RECRUITING
Seattle
Wisconsin
University Hospital
RECRUITING
Madison
Other Locations
Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
TERMINATED
Katowice
Centrum Medyczne Plejady
RECRUITING
Krakow
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
RECRUITING
Krakow
Clinical Research Center Sp. z o.o.
RECRUITING
Poznan
Centrum Medyczne Oporow
ACTIVE_NOT_RECRUITING
Wroclaw
Pracownia Badan Klinicznych SALUS
RECRUITING
Wroclaw
Spain
Centre Atencio Primaria (CAP) Balenya
ACTIVE_NOT_RECRUITING
Balenya
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Clinico Universitario de Valladolid
RECRUITING
Valladolid
Contact Information
Primary
Pfizer Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2021-04-28
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 600
Treatments
Experimental: Active
rimegepant 75 mg, 50 mg or 35 mg ODT
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

Similar Clinical Trials