Clinical trial NCT05156398: Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Migraine prevention
Phonophobia
Photophobia
Nausea
Pediatric migraine
Adolescent migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 640
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

   1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
   2. 6 or more migraine days during the Observation Period
   3. 14 or less headache days during the Observation Period
   4. 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
   5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
   6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
   7. 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.

Exclusion Criteria:

1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3. The subject has a history or diagnosis of complications of migraine
4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
5. 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.
6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
7. History of major psychiatric disorder.
8. The subject has a current diagnosis or history of substance abuse
9. 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.

Primary outcomes:
measure: 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
timeFrame: 3 months (12 weeks)
Secondary outcomes:
measure: 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
timeFrame: 3 months (12 weeks)
measure: 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.
timeFrame: Weeks 1 through 4 of treatment
measure: 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.
timeFrame: Total score at week 12
measure: 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.
timeFrame: 3 months (12 weeks)
measure: 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.
timeFrame: 3 months (12 weeks)
measure: Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.
timeFrame: 3 months (12 weeks)
measure: Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.
timeFrame: 72 Weeks
measure: Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.
timeFrame: 72 Weeks
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: The Belinga Clinic
state: Arkansas
city: Hawthorne
country: United States
facility: Advanced Investigative Medicine, Inc.
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research San Diego
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC
state: Colorado
city: Washington
country: United States
facility: Meridian Clinical Research, LLC
state: District of Columbia
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
city: Edgewater
country: United States
facility: Accel Research Sites Network - Edgewater Clinical Research Unit
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hollywood
country: United States
facility: New Med Research, Inc
state: Florida
city: Ormond Beach
country: United States
facility: Complete Health Research
state: Florida
city: Tamarac
country: United States
facility: D&H Tamarac Research Center LLC
state: Florida
city: Tampa
country: United States
facility: Santos Research Center, CORP
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Snellville
country: United States
facility: Extraordinary Family Healthcare
state: Georgia
city: Snellville
country: United States
facility: Renew Health Clinical Research LLC
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials, Inc.
state: Idaho
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Clinton
country: United States
facility: Safe Haven Clinical Research
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri - Investigational Pharmacy
state: Missouri
city: Grand Island
country: United States
facility: Velocity Clinical Research, Inc.
state: Nebraska
city: Papillion
country: United States
facility: Papillion Research Center/CCT Research
state: Nebraska
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc.
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research LLC
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital & University Health Center
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Medical Group Pediatric Specialists
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Nashville
country: United States
facility: Monroe Carell Jr Children's Hospital at Vanderbilt
state: Tennessee
city: Dallas
country: United States
facility: Alina Clinical Trials, LLC.
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Cy Fair
state: Texas
city: Houston
country: United States
facility: SCLA Management - Drop Box
state: Texas
city: Houston
country: United States
facility: SCLA Management Office
state: Texas
city: Houston
country: United States
facility: NeuroCare Plus
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: McAllen
country: United States
facility: DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: DCT-Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research (Administrative Office Only)
state: Texas
city: Victoria
country: United States
facility: Victoria Clinical Research Group
state: Texas
city: South Ogden
country: United States
facility: South Ogden Family Medicine Ogden Clinic/CCT Research
state: Utah
city: Portsmouth
country: United States
facility: Meridian Clinical Research, LLC
state: Virginia
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of British Columbia
state: British Columbia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Toulouse
country: France
facility: Hopital des Enfants
city: Avellino
country: Italy
facility: Unita di Neurologia, Azienda Ospedaliera San Giuseppe Moscati
state: Avellino/campania
city: Bari
country: Italy
facility: UOSVD Centro Epilessia ed EEG dellEta Evolutiva
state: BARI / Puglia
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: Brescia/lombardy
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
state: Florence/tuscany
city: Latina
country: Italy
facility: Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
state: Latina/lazio
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesu
state: Lazio
city: Roma
country: Italy
facility: IRCCS San Raffaele
state: Lazio
city: Milano
country: Italy
facility: Istituto Neurologico "Carlo Besta" Fondazione IRCCS
state: Lombardia
city: Pavia
country: Italy
facility: U.O. Neuropsichiatria Infantile, IRCCS Fondazione Mondino
state: Lombardia
city: Roma
country: Italy
facility: Dipartimento Materno Infantile e Scienze UroGinecologiche - UOC Pediatria
city: Kasuga-shi
country: Japan
facility: Jinnouchi Neurosurgical Clinic
state: Fukuoka
city: Kiryu-shi
country: Japan
facility: Hikita Pediatric Clinic
state: Gunma
city: Higashinada-ku Kobe-shi
country: Japan
facility: Konan Medical Center
state: Hyōgo
city: Nishinomiya-shi
country: Japan
facility: Yamaguchi Clinic
state: Hyōgo
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Kagoshima-city
country: Japan
facility: Tanaka Neurosurgery & Headache Clinic
state: Kagoshima
city: Kochi-shi
country: Japan
facility: Atago Hospital
state: Kōchi
city: Taihaku-ku Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic
state: Miyagi
city: Abeno-ku Osaka-shi
country: Japan
facility: Tennouji Dai Brain Clinic
state: Osaka
city: Naniwa-ku
country: Japan
facility: Tominaga Clinic
state: Osaka
city: Chuo-ku Saitama-shi
country: Japan
facility: Saitama Neuropsychiatric Institute
state: Saitama
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Hiroshima
country: Japan
facility: LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
state: Dolnoslaskie
city: Lublin
country: Poland
facility: NZOZ Neuromed M. i M. Nastaj Sp. P.
state: Lubelskie
city: Krakow
country: Poland
facility: Wojewodzki Specjalistyczny Szpital Dzieciecy
state: Malopolskie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
state: Mazowieckie
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
state: Slaskie
city: Katowice
country: Poland
facility: Neurologia Slaska Centrum Medyczne
state: Slaskie
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
state: Wielkopolskie
city: Warsaw
country: Poland
facility: Next Stage Sp. Z o.o.
state: WOJ. Mazowieckie
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid (HCUV)
state: Castilla Y LEON
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: LA Coruna
city: Madrid
country: Spain
facility: Instituto de Investigaciones del Sueno
city: Sevilla
country: Spain
facility: Virgen del Rocio Hospital
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: