Clinical trial NCT04743141: Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Treatment of Migraine
Keywords: Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. History of migraine (with or without aura) for ≥ 6 months before Screening.
2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
3. 1 or more migraine days requiring treatment during the Observation Phase.
4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
5. Ability to distinguish between migraine and other types of headaches.
6. Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg.
7. Adequate venous access for blood sampling.
8. Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).

Exclusion Criteria:

1. History of cluster headache or hemiplegic migraine headache.
2. Confounding and clinically significant pain syndrome.
3. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
4. History of suicidal behavior or at risk of self-harm/harm to others.
5. History of major psychiatric disorder.
6. Current diagnosis or history of substance abuse
7. Reported current use of or tested positive at Screening for drugs of abuse.

Primary outcomes:
measure: The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities
timeFrame: 58 weeks
Secondary outcomes:
measure: The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation
timeFrame: 58 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Perseverance Research Center, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center, LLC
state: Arizona
city: Tempe
country: United States
facility: Physicians Research Group
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego, Altman Clinical and Translational Research Institute Clinic
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research
state: California
city: Long Beach
country: United States
facility: Memorialcare Miller Children's & Women's Hospital Long Beach
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research - North Hollywood
state: California
city: Pomona
country: United States
facility: The Neurology Group
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
state: California
city: Sacramento
country: United States
facility: University of California, Davis Clinical and Translational Science Center Clinical Research Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Midtown Clinic
state: California
city: San Bernardino
country: United States
facility: Velocity Clinical Research- Banning
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group LLC
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado- Investigational Drug Services
state: Colorado
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Grand Junction
country: United States
facility: Boeson Research GJT
state: Colorado
city: Grand Junction
country: United States
facility: Dinosaur Pediatrics
state: Colorado
city: Grand Junction
country: United States
facility: Boeson Research GJT
state: Colorado
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners, LLc, dba New England Institute for Clinical Research
state: Connecticut
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV, Inc
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Medical Research Center of Miami II, Inc
state: Florida
city: Miami
country: United States
facility: Brainstorm Research
state: Florida
city: Orange Park
country: United States
facility: Coastal Clinical Research Specialists
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Atlanta
country: United States
facility: Childrens Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Rare Disease Research LLC
state: Georgia
city: Brunswick
country: United States
facility: Pivotal Clinical Research & Associates, LLC
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Chicago
country: United States
facility: Chicago Headache Center & Research Institute
state: Illinois
city: Noblesville
country: United States
facility: Physicians Research Group (Administrative Office Location)
state: Indiana
city: Westfield
country: United States
facility: Options Research Group, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
state: Michigan
city: Kalamazoo
country: United States
facility: Wellnow Urgent Care and Research
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital, Royal Oak Campus
state: Michigan
city: Ozark
country: United States
facility: Sharlin Health Neuroscience Research Center
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
city: Great Falls
country: United States
facility: Boeson Research
state: Montana
city: Kalispell
country: United States
facility: Boeson Research,LLC
state: Montana
city: Missoula
country: United States
facility: Boeson Research
state: Montana
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: Neptune
country: United States
facility: HMH Jersey Shore University Medical Center
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Commack
country: United States
facility: True North Neurology
state: New York
city: New York
country: United States
facility: New York Neurology Associates
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital - Pharmacy Department
state: New York
city: New York
country: United States
facility: Columbia University Medical Center Research Pharmacy
state: New York
city: New York
country: United States
facility: Columbia University Pediatric Neuromuscular Center
state: New York
city: New York
country: United States
facility: Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
state: New York
city: New York
country: United States
facility: The Neurological Institute of New York
state: New York
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center, PC
state: North Carolina
city: Cincinnati
country: United States
facility: WellNow Urgent Care and Research
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Drug Delivery-Cincinnati Children's IDS Denise Lagory
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Dayton
country: United States
facility: Wellnow Urgent Care and Research
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Grants Pass
country: United States
facility: Velocity Clinical Research, Grants Pass
state: Oregon
city: Portland
country: United States
facility: Providence Brain & Spine Institute-research coordinator's office
state: Oregon
city: Portland
country: United States
facility: Providence Health & Services Investigational Drug Services Westside
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence
state: Rhode Island
city: Greenville
country: United States
facility: Tribe Clinical Research LLC
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research- Greenville
state: South Carolina
city: Greer
country: United States
facility: Premier Neurology
state: South Carolina
city: Clarksville
country: United States
facility: Novaceut Clinical Research
state: Tennessee
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Memphis
country: United States
facility: Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Le Bonheur Childrens Hospital - Outpatient Building
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc.
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Austin
country: United States
facility: Child Neurology Consultants of Austin - South Austin
state: Texas
city: Austin
country: United States
facility: Child Neurology Consultants of Austin - Central Austin
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: El Paso
country: United States
facility: ANRC Research
state: Texas
city: Frisco
country: United States
facility: North Texas Institute of Neurology and Headache
state: Texas
city: Houston
country: United States
facility: Trio Clinical Trials, LLC.
state: Texas
city: Houston
country: United States
facility: Pain and Headache Centers of Texas
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research,LLC.
state: Texas
city: Houston
country: United States
facility: NeuroCare Plus
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research , LLC(Administrative Location)
state: Utah
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters
state: Virginia
city: Norfolk
country: United States
facility: Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital Investigational Drug Services
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Madison
country: United States
facility: University Hospital
state: Wisconsin
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
city: Poznań
country: Poland
facility: Clinical Research Center Sp. z o.o.
city: Wroclaw
country: Poland
facility: Pracownia Badan Klinicznych SALUS
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Balenya
country: Spain
facility: Centre Atencio Primaria (CAP) Balenya
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: