A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age

Who is this study for? Children and adolescents with episodic migraine
What treatments are being studied? Rimegepant
Status: Recruiting
Location: See all (93) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.

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

• Subject has at least a 6 month history of migraine (with or without aura) and including the following:

‣ 14 or less headache days per month during the 3 month period prior to the Screening Visit

⁃ 6 or more migraine days during the Observation Period

⁃ 14 or less headache days during the Observation Period

⁃ Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit

⁃ Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches

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

⁃ Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent.

∙ Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.

Locations
United States
Arkansas
The Belinga Clinic
ACTIVE_NOT_RECRUITING
Fort Smith
California
Advanced Investigative Medicine, Inc.
RECRUITING
Hawthorne
Velocity Clinical Research San Diego
ACTIVE_NOT_RECRUITING
La Mesa
Colorado
Colorado Springs Neurological Associates
ACTIVE_NOT_RECRUITING
Colorado Springs
Advanced Neurosciences Research, LLC
TERMINATED
Fort Collins
Washington, D.c.
Meridian Clinical Research, LLC
RECRUITING
Washington D.c.
Florida
Synergy Healthcare
RECRUITING
Bradenton
Accel Research Sites Network - Edgewater Clinical Research Unit
ACTIVE_NOT_RECRUITING
Edgewater
Direct Helpers Research Center
RECRUITING
Hialeah
New Med Research, Inc
TERMINATED
Hollywood
Complete Health Research
ACTIVE_NOT_RECRUITING
Ormond Beach
D&H Tamarac Research Center LLC
RECRUITING
Tamarac
Santos Research Center, CORP
RECRUITING
Tampa
Georgia
Augusta University
RECRUITING
Augusta
WR-Mount Vernon Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Sandy Springs
Meridian Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Savannah
Extraordinary Family Healthcare
ACTIVE_NOT_RECRUITING
Snellville
Renew Health Clinical Research LLC
ACTIVE_NOT_RECRUITING
Snellville
Idaho
Northwest Clinical Trials, Inc.
RECRUITING
Boise
Illinois
Diamond Headache Clinic
TERMINATED
Chicago
Louisiana
Nola Research Works, LLC
RECRUITING
New Orleans
Missouri
Roy Blunt NextGen Precision Health Building
RECRUITING
Columbia
University of Missouri - Investigational Pharmacy
RECRUITING
Columbia
University of Missouri-Clinical and Translational Sciences Unit
RECRUITING
Columbia
Mississippi
Safe Haven Clinical Research
RECRUITING
Clinton
North Carolina
Carolina Institute for Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Fayetteville
Nebraska
Velocity Clinical Research, Inc.
RECRUITING
Grand Island
Papillion Research Center/CCT Research
RECRUITING
Papillion
Nevada
Renown Regional Medical Center
ACTIVE_NOT_RECRUITING
Reno
New York
Dent Neurosciences Research Center, Inc.
ACTIVE_NOT_RECRUITING
Amherst
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Velocity Clinical Research
ACTIVE_NOT_RECRUITING
Cincinnati
Oklahoma
Lynn Health Science Institute
ACTIVE_NOT_RECRUITING
Oklahoma City
South Carolina
Coastal Pediatric Research
ACTIVE_NOT_RECRUITING
Charleston
Tribe Clinical Research LLC
TERMINATED
Greenville
South Dakota
Avera McKennan Hospital & University Health Center
RECRUITING
Sioux Falls
Avera Medical Group Pediatrics - Dawley Farm
RECRUITING
Sioux Falls
Avera Research Institute
RECRUITING
Sioux Falls
Tennessee
Monroe Carell Jr Children's Hospital at Vanderbilt
TERMINATED
Nashville
Texas
Alina Clinical Trials, LLC.
RECRUITING
Dallas
North Texas Center for Clinical Research
RECRUITING
Frisco
DM Clinical Research - Cy Fair
RECRUITING
Houston
NeuroCare Plus
RECRUITING
Houston
SCLA Management - Drop Box
RECRUITING
Houston
SCLA Management Office
RECRUITING
Houston
Red Star Research, LLC
RECRUITING
Lake Jackson
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
RECRUITING
Mcallen
DCT-Stone Oak, LLC dba Discovery Clinical Trials
RECRUITING
San Antonio
Texas Institute for Neurological Disorders
ACTIVE_NOT_RECRUITING
Sherman
DM Clinical Research (Administrative Office Only)
RECRUITING
Tomball
Victoria Clinical Research Group
RECRUITING
Victoria
Virginia
Meridian Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Portsmouth
Other Locations
Canada
Children's and Women's Health Centre of British Columbia
TERMINATED
Vancouver
France
Centre Hospitalier Intercommunal de Créteil
NOT_YET_RECRUITING
Créteil
Centre Hospitalier Universitaire de Montpellier
RECRUITING
Montpellier
Hopital des Enfants
RECRUITING
Toulouse
Italy
UOSVD Centro Epilessia ed EEG dellEta Evolutiva
RECRUITING
Bari
Spedali Civili di Brescia
RECRUITING
Brescia
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
RECRUITING
Latina
Istituto Neurologico Carlo Besta Fondazione IRCCS
NOT_YET_RECRUITING
Milan
U.O. Neuropsichiatria Infantile, IRCCS Fondazione Mondino
NOT_YET_RECRUITING
Pavia
Dipartimento Materno Infantile e Scienze UroGinecologiche - UOC Pediatria
RECRUITING
Roma
IRCCS San Raffaele
RECRUITING
Rome
Ospedale Pediatrico Bambino Gesu
RECRUITING
Rome
Japan
Tennouji Dai Brain Clinic
RECRUITING
Abeno-ku Osaka-shi
Saitama Neuropsychiatric Institute
RECRUITING
Chuo-ku Saitama-shi
Konan Medical Center
RECRUITING
Higashinada-ku Kobe-shi
LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
NOT_YET_RECRUITING
Hiroshima
Tanaka Neurosurgery & Headache Clinic
RECRUITING
Kagoshima
Jinnouchi Neurosurgical Clinic
RECRUITING
Kasuga-shi
Hikita Pediatric Clinic
RECRUITING
Kiryu-shi
Atago Hospital
RECRUITING
Kochi
Mito Kyodo General Hospital
NOT_YET_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
Poland
Neurologia Slaska Centrum Medyczne
RECRUITING
Katowice
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
ACTIVE_NOT_RECRUITING
Katowice
Wojewodzki Specjalistyczny Szpital Dzieciecy
RECRUITING
Krakow
NZOZ Neuromed M. i M. Nastaj Sp. P.
RECRUITING
Lublin
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
RECRUITING
Poznan
MTZ Clinical Research Powered by Pratia
RECRUITING
Warsaw
Next Stage Sp. Z o.o.
RECRUITING
Warsaw
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
RECRUITING
Wroclaw
Spain
Instituto de Investigaciones del Sueno
NOT_YET_RECRUITING
Madrid
Hospital Universitari Parc Tauli
RECRUITING
Sabadell
Virgen del Rocio Hospital
RECRUITING
Seville
Hospital Universitario y Politecnico La Fe
RECRUITING
Valencia
Hospital Clinico Universitario de Valladolid (HCUV)
RECRUITING
Valladolid
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Contact Information
Primary
Pfizer Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-02-28
Estimated Completion Date: 2032-11-27
Participants
Target number of participants: 640
Treatments
Active_comparator: Rimegepant / BHV3000
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Placebo_comparator: Matching Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov