Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
- Registration Number
- NCT05156398
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 640
-
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.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
-
- Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
- The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- The subject has a history or diagnosis of complications of migraine
- The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
- The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
- History of suicidal behavior or the subject is at risk of self-harm or harm to others.
- History of major psychiatric disorder.
- The subject has a current diagnosis or history of substance abuse
- The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Rimegepant / BHV3000 Rimegepant Rimegepant 75mg or 50mg (2 X 25mg) ODT Matching Placebo Placebo Matching placebo 75mg or 50mg (2 X 25mg) ODT
- Primary Outcome Measures
Name Time Method Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine 3 months (12 weeks) Reduction from baseline in mean number of migraine days per month
- Secondary Outcome Measures
Name Time Method Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine 3 months (12 weeks) Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine. 3 months (12 weeks) Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days. 3 months (12 weeks) Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine. Weeks 1 through 4 of treatment The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine. Total score at week 12 Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month. 3 months (12 weeks) Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents. 72 Weeks This will be evaluated by the number of subjects with treatment related adverse events by severity.
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant. 72 Weeks Measured by discontinuations in treated subjects due to elevated liver function tests.
Trial Locations
- Locations (93)
Wojewodzki Specjalistyczny Szpital Dzieciecy
🇵🇱Krakow, Malopolskie, Poland
Diamond Headache Clinic
🇺🇸Chicago, Illinois, United States
The Belinga Clinic
🇺🇸Fort Smith, Arkansas, United States
Advanced Investigative Medicine, Inc.
🇺🇸Hawthorne, California, United States
Velocity Clinical Research San Diego
🇺🇸La Mesa, California, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Advanced Neurosciences Research, LLC
🇺🇸Fort Collins, Colorado, United States
Meridian Clinical Research, LLC
🇺🇸Portsmouth, Virginia, United States
Synergy Healthcare
🇺🇸Bradenton, Florida, United States
Accel Research Sites Network - Edgewater Clinical Research Unit
🇺🇸Edgewater, Florida, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
New Med Research, Inc
🇺🇸Hollywood, Florida, United States
Complete Health Research
🇺🇸Ormond Beach, Florida, United States
D&H Tamarac Research Center LLC
🇺🇸Tamarac, Florida, United States
Santos Research Center, CORP
🇺🇸Tampa, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
WR-Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Extraordinary Family Healthcare
🇺🇸Snellville, Georgia, United States
Renew Health Clinical Research LLC
🇺🇸Snellville, Georgia, United States
Northwest Clinical Trials, Inc.
🇺🇸Boise, Idaho, United States
Safe Haven Clinical Research
🇺🇸Clinton, Mississippi, United States
University of Missouri - Investigational Pharmacy
🇺🇸Columbia, Missouri, United States
Velocity Clinical Research, Inc.
🇺🇸Grand Island, Nebraska, United States
Papillion Research Center/CCT Research
🇺🇸Papillion, Nebraska, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Dent Neurosciences Research Center, Inc.
🇺🇸Amherst, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Carolina Institute for Clinical Research, LLC
🇺🇸Fayetteville, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research
🇺🇸Cincinnati, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Tribe Clinical Research LLC
🇺🇸Greenville, South Carolina, United States
Avera McKennan Hospital & University Health Center
🇺🇸Sioux Falls, South Dakota, United States
Avera Medical Group Pediatric Specialists
🇺🇸Sioux Falls, South Dakota, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Monroe Carell Jr Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Alina Clinical Trials, LLC.
🇺🇸Dallas, Texas, United States
North Texas Center for Clinical Research
🇺🇸Frisco, Texas, United States
DM Clinical Research - Cy Fair
🇺🇸Houston, Texas, United States
SCLA Management - Drop Box
🇺🇸Houston, Texas, United States
SCLA Management Office
🇺🇸Houston, Texas, United States
NeuroCare Plus
🇺🇸Houston, Texas, United States
Red Star Research, LLC
🇺🇸Lake Jackson, Texas, United States
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
🇺🇸McAllen, Texas, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
Texas Institute for Neurological Disorders
🇺🇸Sherman, Texas, United States
DM Clinical Research (Administrative Office Only)
🇺🇸Tomball, Texas, United States
Victoria Clinical Research Group
🇺🇸Victoria, Texas, United States
South Ogden Family Medicine Ogden Clinic/CCT Research
🇺🇸South Ogden, Utah, United States
Children's and Women's Health Centre of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Centre Hospitalier Intercommunal de Créteil
🇫🇷Créteil, France
Centre Hospitalier Universitaire de Montpellier
🇫🇷Montpellier, France
Hopital des Enfants
🇫🇷Toulouse, France
Unita di Neurologia, Azienda Ospedaliera San Giuseppe Moscati
🇮🇹Avellino, Avellino/campania, Italy
UOSVD Centro Epilessia ed EEG dellEta Evolutiva
🇮🇹Bari, BARI / Puglia, Italy
Spedali Civili di Brescia
🇮🇹Brescia, Brescia/lombardy, Italy
Azienda Ospedaliero Universitaria Meyer
🇮🇹Florence, Florence/tuscany, Italy
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
🇮🇹Latina, Latina/lazio, Italy
Ospedale Pediatrico Bambino Gesu
🇮🇹Roma, Lazio, Italy
IRCCS San Raffaele
🇮🇹Roma, Lazio, Italy
Istituto Neurologico "Carlo Besta" Fondazione IRCCS
🇮🇹Milano, Lombardia, Italy
U.O. Neuropsichiatria Infantile, IRCCS Fondazione Mondino
🇮🇹Pavia, Lombardia, Italy
Dipartimento Materno Infantile e Scienze UroGinecologiche - UOC Pediatria
🇮🇹Roma, Italy
Jinnouchi Neurosurgical Clinic
🇯🇵Kasuga-shi, Fukuoka, Japan
Hikita Pediatric Clinic
🇯🇵Kiryu-shi, Gunma, Japan
Konan Medical Center
🇯🇵Higashinada-ku Kobe-shi, Hyōgo, Japan
Yamaguchi Clinic
🇯🇵Nishinomiya-shi, Hyōgo, Japan
Mito Kyodo General Hospital
🇯🇵Mito-shi, Ibaraki, Japan
Tanaka Neurosurgery & Headache Clinic
🇯🇵Kagoshima-city, Kagoshima, Japan
Atago Hospital
🇯🇵Kochi-shi, Kōchi, Japan
Sendai Headache and Neurology Clinic
🇯🇵Taihaku-ku Sendai-shi, Miyagi, Japan
Tennouji Dai Brain Clinic
🇯🇵Abeno-ku Osaka-shi, Osaka, Japan
Tominaga Clinic
🇯🇵Naniwa-ku, Osaka, Japan
Saitama Neuropsychiatric Institute
🇯🇵Chuo-ku Saitama-shi, Saitama, Japan
Tokyo Headache Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima, Japan
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
🇵🇱Wroclaw, Dolnoslaskie, Poland
NZOZ Neuromed M. i M. Nastaj Sp. P.
🇵🇱Lublin, Lubelskie, Poland
MTZ Clinical Research Powered by Pratia
🇵🇱Warszawa, Mazowieckie, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
🇵🇱Katowice, Slaskie, Poland
Neurologia Slaska Centrum Medyczne
🇵🇱Katowice, Slaskie, Poland
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
🇵🇱Poznan, Wielkopolskie, Poland
Next Stage Sp. Z o.o.
🇵🇱Warsaw, WOJ. Mazowieckie, Poland
Hospital Universitari Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Hospital Clinico Universitario de Valladolid (HCUV)
🇪🇸Valladolid, Castilla Y LEON, Spain
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Galicia, Spain
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, LA Coruna, Spain
Instituto de Investigaciones del Sueno
🇪🇸Madrid, Spain
Virgen del Rocio Hospital
🇪🇸Sevilla, Spain
Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain