Epilepsy Clinical Trials

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Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the 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 (245) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

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 according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).

• History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours.

• Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.

‣ Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.

⁃ Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.

⁃ Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.

• Verbally distinguish between migraine and other types of headaches.

• Participants must have a weight \> 40 kg at the Screening Visit.

• Adequate venous access for blood sampling.

• Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study).

Locations
United States
Alabama
Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama
ACTIVE_NOT_RECRUITING
Birmingham
Arizona
Perseverance Research Center, LLC
RECRUITING
Scottsdale
Physicians Research Group
ACTIVE_NOT_RECRUITING
Tempe
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
Adult & Child Neurology Medical Associates
RECRUITING
Costa Mesa
ProScience Research Group
ACTIVE_NOT_RECRUITING
Culver City
Memorial Health Services
RECRUITING
Fountain Valley
Neuro-Pain Research Center
RECRUITING
Fresno
Altman Clinical and Translational Research Institute, University of California San Diego
RECRUITING
La Jolla
Adult & Child Neurology Medical Associates
RECRUITING
Long Beach
Miller Children's & Women's Hospital Long Beach
RECRUITING
Long Beach
National Research Institute
ACTIVE_NOT_RECRUITING
Los Angeles
Velocity Clinical Research - North Hollywood
ACTIVE_NOT_RECRUITING
North Hollywood
Children's Hospital of Orange County
NOT_YET_RECRUITING
Orange
Children's Hospital of Orange County - Inpatient Pharmacy
NOT_YET_RECRUITING
Orange
Children's Hospital of Orange County - Neuroscience Center
NOT_YET_RECRUITING
Orange
The Neurology Group
RECRUITING
Pomona
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
ACTIVE_NOT_RECRUITING
Sacramento
University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
ACTIVE_NOT_RECRUITING
Sacramento
University of California, Davis Midtown Clinic
ACTIVE_NOT_RECRUITING
Sacramento
Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)
RECRUITING
San Bernardino
Pacific Clinical Research Management Group LLC
ACTIVE_NOT_RECRUITING
Upland
Sunwise Clinical Research
RECRUITING
Walnut Creek
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Children's Hospital Colorado- lnvestigational Drug Services
RECRUITING
Aurora
Colorado Springs Neurological Associates, PC
ACTIVE_NOT_RECRUITING
Colorado Springs
Colorado Springs Neurological Associates, PC
ACTIVE_NOT_RECRUITING
Colorado Springs
Connecticut
CT Clinical Research
RECRUITING
Cromwell
Connecticut Children's Medical Center
ACTIVE_NOT_RECRUITING
Hartford
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.
Delaware
Nemours Children's Hospital, Delaware
ACTIVE_NOT_RECRUITING
Wilmington
Florida
Topaz Clinical Research, Inc.
ACTIVE_NOT_RECRUITING
Apopka
Beautiful Minds Clinical Research Center
TERMINATED
Cutler Bay
DeLand Clinical Research Unit
TERMINATED
Deland
Sarkis Clinical Trials
ACTIVE_NOT_RECRUITING
Gainesville
Multi-Specialty Research Associates, Inc.
ACTIVE_NOT_RECRUITING
Lake City
Watson Clinic Center for Research, Inc.
TERMINATED
Lakeland
Watson Clinic LLP
TERMINATED
Lakeland
AppleMed Research Group, LLC
ACTIVE_NOT_RECRUITING
Miami
Brainstorm Research
ACTIVE_NOT_RECRUITING
Miami
Medical Research Center of Miami II, Inc
ACTIVE_NOT_RECRUITING
Miami
South Florida Research Phase I-IV, Inc
RECRUITING
Miami
Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office
ACTIVE_NOT_RECRUITING
Naples
Aqualane Clinical Research
RECRUITING
Naples
Coastal Clinical Research Specialists
ACTIVE_NOT_RECRUITING
Orange Park
Clinical Associates of Orlando, LLC
RECRUITING
Orlando
Bioresearch Institute
TERMINATED
Pembroke Pines
Forcare Clinical Research
ACTIVE_NOT_RECRUITING
Tampa
Premiere Research Institute at Palm Beach Neurology
ACTIVE_NOT_RECRUITING
West Palm Beach
Georgia
Children's Healthcare of Atlanta, Inc.
ACTIVE_NOT_RECRUITING
Atlanta
Childrens Healthcare of Atlanta
ACTIVE_NOT_RECRUITING
Atlanta
Rare Disease Research, LLC
ACTIVE_NOT_RECRUITING
Atlanta
Pivotal Clinical Research & Associates, LLC
RECRUITING
Brunswick
CenExel iResearch, LLC
RECRUITING
Decatur
Iowa
Velocity Clinical Research, Sioux City
RECRUITING
Sioux City
Integrated Clinical Trial Services
RECRUITING
West Des Moines
Illinois
Chicago Headache Center & Research Institute
RECRUITING
Chicago
AMR-Baber Research Inc
RECRUITING
Naperville
Indiana
Options Research Group, LLC
RECRUITING
Westfield
Kansas
Clinical Associates Midwest, LLC
RECRUITING
Kansas City
College Park Family Care Center Physicians Group- Neurology Research Dept.
ACTIVE_NOT_RECRUITING
Overland Park
Kentucky
Kentucky Neuroscience Institute Child Neurology-- Patients Seen
ACTIVE_NOT_RECRUITING
Lexington
UK Center for Clinical and Translational Science (CCTS) -- Patients Seen
ACTIVE_NOT_RECRUITING
Lexington
University of Kentucky Hospital
ACTIVE_NOT_RECRUITING
Lexington
Louisiana
Ochsner Clinic Foundation
ACTIVE_NOT_RECRUITING
New Orleans
Neurology and Headache Center, Inc.
ACTIVE_NOT_RECRUITING
Shreveport
Massachusetts
Boston Clinical Trials
ACTIVE_NOT_RECRUITING
Boston
MedVadis Research Corporation
ACTIVE_NOT_RECRUITING
Waltham
Michigan
Michigan Head Pain & 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
ACTIVE_NOT_RECRUITING
Kalamazoo
Beaumont Hospital Royal Oak Campus
RECRUITING
Royal Oak
Minnesota
Brackenridge Outpatient Research Pharmacy
RECRUITING
Rochester
Clinical Research Trials Unit
RECRUITING
Rochester
Mayo Clinic
RECRUITING
Rochester
Missouri
Sharlin Health Neuroscience Research Center
ACTIVE_NOT_RECRUITING
Ozark
Clinvest Research, LLC
ACTIVE_NOT_RECRUITING
Springfield
Mississippi
Precise Research Centers
RECRUITING
Flowood
Montana
Boeson Research
RECRUITING
Great Falls
Boeson Research
ACTIVE_NOT_RECRUITING
Kalispell
Heart & Hands Midwifery
ACTIVE_NOT_RECRUITING
Kalispell
Blue Moose Pediatrics
RECRUITING
Missoula
Boeson Research
RECRUITING
Missoula
Boeson Research Laboratory
RECRUITING
Missoula
North Carolina
New Hope Clinical Research
ACTIVE_NOT_RECRUITING
Charlotte
OnSite Clinical Solutions, LLC
RECRUITING
Charlotte
Headache Wellness Center, PC
ACTIVE_NOT_RECRUITING
Greensboro
Nebraska
Alivation Research, LLC.
TERMINATED
Lincoln
Children's Hospital & Medical Center
RECRUITING
Omaha
New Jersey
HMH Jersey Shore University Medical Center
RECRUITING
Neptune City
HOPE Tower at Jersey Shore University Medical Center
RECRUITING
Neptune City
New York
Dent Neurosciences Research Center
RECRUITING
Amherst
True North Neurology
RECRUITING
Commack
Northwell Health/ Division of Pediatric Neurology
RECRUITING
Lake Success
NYU Langone Hospital-Long Island, Clinical Research Center
ACTIVE_NOT_RECRUITING
Mineola
NYU Langone Hospital-Long Island, Pediatric Neurology
ACTIVE_NOT_RECRUITING
Mineola
Columbia University Medical Center Research Pharmacy
ACTIVE_NOT_RECRUITING
New York
Columbia University Pediatric Neuromuscular Center
ACTIVE_NOT_RECRUITING
New York
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
ACTIVE_NOT_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
ACTIVE_NOT_RECRUITING
New York
The Trustees of Columbia University and The New York and Presbyterian Hospital
ACTIVE_NOT_RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
North Suffolk Neurology P.C
ACTIVE_NOT_RECRUITING
Port Jefferson Station
Finger Lakes Clinical Research
TERMINATED
Rochester
Prime Global Research, LLC
TERMINATED
The Bronx
Ohio
Akron Children's Hospital
ACTIVE_NOT_RECRUITING
Akron
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Velocity Clinical Research
ACTIVE_NOT_RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Nationwide Children's Hospital
ACTIVE_NOT_RECRUITING
Columbus
Wellnow Urgent Care and Research
ACTIVE_NOT_RECRUITING
Columbus
Neuro-Behavioral Clinical Research, Inc.
ACTIVE_NOT_RECRUITING
North Canton
Oklahoma
IPS Research Company
ACTIVE_NOT_RECRUITING
Oklahoma City
Lynn Institute of Tulsa
ACTIVE_NOT_RECRUITING
Tulsa
Oregon
Velocity Clinical Research, Grants Pass
ACTIVE_NOT_RECRUITING
Grants Pass
Providence Neuroscience Institute - Research Coordinator's Office
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
Premier Neurology, PC
ACTIVE_NOT_RECRUITING
Greenville
Tribe Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Greenville
Velocity Clinical Research - Greenville
ACTIVE_NOT_RECRUITING
Greenville
Tennessee
Holston Medical Group
ACTIVE_NOT_RECRUITING
Kingsport
Holston Medical Group.
ACTIVE_NOT_RECRUITING
Kingsport
Le Bonheur Children's Hospital
ACTIVE_NOT_RECRUITING
Memphis
Le Bonheur Children's Hospital - Outpatient Building
ACTIVE_NOT_RECRUITING
Memphis
Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
ACTIVE_NOT_RECRUITING
Memphis
Access Clinical Trials, Inc.
ACTIVE_NOT_RECRUITING
Nashville
Texas
BioBehavioral Research of Austin
ACTIVE_NOT_RECRUITING
Austin
Child Neurology Consultants of Austin - Central Austin
ACTIVE_NOT_RECRUITING
Austin
Child Neurology Consultants of Austin - South Austin
ACTIVE_NOT_RECRUITING
Austin
Dell Children's Medical Center
RECRUITING
Austin
Houston Clinical Trials, LLC
RECRUITING
Bellaire
Cedar Health Research
ACTIVE_NOT_RECRUITING
Dallas
Children's Medical Center, Dallas
ACTIVE_NOT_RECRUITING
Dallas
Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
ACTIVE_NOT_RECRUITING
Dallas
FutureSearch Trials of Dallas, LLC
RECRUITING
Dallas
Infinite Research Group, LLC
ACTIVE_NOT_RECRUITING
Dallas
The University of Texas Southwestern Medical Center
ACTIVE_NOT_RECRUITING
Dallas
ANESC Research
RECRUITING
El Paso
North Texas Institute of Neurology and Headache
ACTIVE_NOT_RECRUITING
Frisco
Houston Clinical Research,LLC.
ACTIVE_NOT_RECRUITING
Houston
NeuroCare Plus
RECRUITING
Houston
Pain and Headache Centers of Texas
RECRUITING
Houston
SCLA Management
RECRUITING
Houston
UTHealth Houston
RECRUITING
Houston
AIM Trials, LLC
ACTIVE_NOT_RECRUITING
Plano
Utah
JBR Clinical Research
RECRUITING
Salt Lake City
Wasatch Clinical Research , LLC(Administrative Location)
RECRUITING
Salt Lake City
Virginia
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
RECRUITING
Charlottesville
Pediatric Research of Charlottesville, LLC
RECRUITING
Charlottesville
Pediatric Research of Charlottesville, LLC (Regulatory Only)
RECRUITING
Charlottesville
Children's Hospital of the King's Daughters
RECRUITING
Norfolk
Children's Specialty Group, PLLC
RECRUITING
Norfolk
Children's Specialty Group, PLLC, Division of Childhood & Adolescent Neurology
RECRUITING
Norfolk
National Clinical Research, Inc.
ACTIVE_NOT_RECRUITING
Richmond
Vermont
The University of Vermont Medical Center
ACTIVE_NOT_RECRUITING
Burlington
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
ACTIVE_NOT_RECRUITING
Everett
Seattle Children's Hospital
RECRUITING
Seattle
Seattle Children's Hospital Investigational Drug Services
RECRUITING
Seattle
Wisconsin
Clinical Investigation Specialists, Inc
RECRUITING
Kenosha
University Hospital
RECRUITING
Madison
Other Locations
Canada
Kelowna Health & Memory Centre
RECRUITING
Kelowna Bc
Diex Recherche Sherbrooke Inc
ACTIVE_NOT_RECRUITING
Sherbrooke
China
Chinese PLA General Hospital
ACTIVE_NOT_RECRUITING
Beijing
First Affiliated Hospital of Bengbu Medical College Neurology
ACTIVE_NOT_RECRUITING
Bengbu
The First Hospital of Jilin University, Pediatric Neurology
RECRUITING
Changchun
Hunan Children's Hospital
RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
West China Hospital of Sichuan University
ACTIVE_NOT_RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Hainan General Hospital
ACTIVE_NOT_RECRUITING
Haikou
Children's Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Shandong Provincial Qianfoshan Hospital
RECRUITING
Jinan
Jingzhou First People's Hospital
ACTIVE_NOT_RECRUITING
Jingzhou
Lanzhou university second hospital
ACTIVE_NOT_RECRUITING
Lanzhou
The Second People's Hospital of Lianyungang
RECRUITING
Lianyungang
Liaocheng People's Hospital
RECRUITING
Liaocheng
Lu 'an People's Hospital
RECRUITING
Lu'an
Ningbo Women and Children's Hospital
ACTIVE_NOT_RECRUITING
Ningbo
Children's Hospital of Shanghai
ACTIVE_NOT_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Shenzhen Children's Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Shihezi University School of Medicine
ACTIVE_NOT_RECRUITING
Shihezi
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The Second Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
ACTIVE_NOT_RECRUITING
Wuhan
Wuhan Children's Hospital
RECRUITING
Wuhan
Affiliated Hospital of Jiangnan University
RECRUITING
Wuxi
Wuxi Children's Hospital
RECRUITING
Wuxi
Shaanxi Provincial People's Hospital
ACTIVE_NOT_RECRUITING
Xi'an
Xi'an Gaoxin Hospital Neurology Department
ACTIVE_NOT_RECRUITING
Xi'an
Yan 'an University Xianyang Hospital
RECRUITING
Xianyang
Xuzhou Children's Hospital
RECRUITING
Xuzhou
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
People's Hospital of Zhengzhou
RECRUITING
Zhengzhou
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Japan
Tennoji Dai Brain Clinic
RECRUITING
Abeno-ku Osaka-shi
Konan Medical Center
RECRUITING
Higashinada-ku Kobe-shi
Local lndependent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City
ACTIVE_NOT_RECRUITING
Hiroshima
Tanaka Neurosurgery & Headache Clinic
RECRUITING
Kagoshima
Ikeda Neurosurgical Clinic
RECRUITING
Kasuga-shi
Jinnouchi Neurosurgical Clinic
RECRUITING
Kasuga-shi
Hikita Pediatric Clinic
RECRUITING
Kiryu-shi
Mito Kyodo General Hospital
RECRUITING
Mito
Tominaga Clinic
RECRUITING
Naniwa-ku
Yamaguchi Clinic
RECRUITING
Nishinomiya-shi
Tokyo Headache Clinic
RECRUITING
Shibuya-ku
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Sendai Headache and Neurology Clinic
RECRUITING
Taihaku-ku Sendai-shi
Mexico
Unidad de Investigacion en Salud de Chihuahua S.C.
RECRUITING
Chihuahua City
Clinstile S.A. de C.V.
RECRUITING
Col. Roma Norte
Neurociencias Estudios Clinicos S.C.
ACTIVE_NOT_RECRUITING
Culiacán
Clinical Reseach Institute, S.C.
RECRUITING
Tlalnepantla
Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
ACTIVE_NOT_RECRUITING
Katowice
Centrum Medyczne Plejady
RECRUITING
Krakow
Oddzial Kliniczny Dzieci Starszych z Pododdzialami: Neurologicznym, Reumatologicznym
RECRUITING
Krakow
Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
RECRUITING
Krakow
Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, Apteka Szpitalna
RECRUITING
Krakow
Clinical Research Center Sp. z.o.o. Medic-R Spolka komandytowa
RECRUITING
Poznan
Euromedis Sp. z o. o.
ACTIVE_NOT_RECRUITING
Szczecin
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
RECRUITING
Wroclaw
Spain
Centre d'Atencio Primaria Balenya
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Instituto de Investigaciones del Sueno
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla
ACTIVE_NOT_RECRUITING
Santander
Hospital Universitario Virgen del Rocío
ACTIVE_NOT_RECRUITING
Seville
Hospital Clinico Universitario de Valladolid
RECRUITING
Valladolid
Sweden
ProbarE i Lund AB
RECRUITING
Lund
Avdelningen för kliniska Prövningar, Universitetssjukhuset Örebro
ACTIVE_NOT_RECRUITING
Örebro
ProbarE i Stockholm AB
RECRUITING
Stockholm
United Kingdom
Leicester Royal Infirmary
ACTIVE_NOT_RECRUITING
Leicester
Great Ormond Street Hospital for Children NHS Foundation Trust
RECRUITING
London
Re:Cognition Health Limited
RECRUITING
London
Contact Information
Primary
Pfizer Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2021-01-15
Estimated Completion Date: 2029-01-09
Participants
Target number of participants: 2100
Treatments
Active_comparator: BHV3000 (active drug)
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Placebo_comparator: Placebo
Matching 75 mg or 50 mg ODT placebo
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov