Clinical trial NCT06616194: A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Official title: AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: Chronic migraine
adolescents
rimegepant,
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.

Rimegepant is a tablet that dissolves when you put it on or under your tongue.

The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours

In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.

Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.

In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.

Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.


Eligibility criteria: Inclusion Criteria:

* At least a 6 month history of migraine (with or without aura)
* 15 or more headache days/month
* 8 or more migraine days/month
* Migraine lasting 4-72 hours if untreated

Exclusion Criteria:

* Unrelenting headache
* Current psychiatric condition uncontrolled or untreated
* History of suicidal behavior or the subject is at risk of self-harm
* History of alcohol abuse and/or illicit drug use
* History of severe drug allergy
* Use of more than one medication for migraine prevention/prophylaxis
* Participation in another clinical trial at the same time

Primary outcomes:
measure: Number of migraine days per month
timeFrame: 12 Weeks
Secondary outcomes:
measure: Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month
timeFrame: 12 Weeks
measure: Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month
timeFrame: 12 Weeks
measure: Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month
timeFrame: 12 weeks
measure: Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score
timeFrame: 12 Weeks
measure: Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month
timeFrame: 12 Weeks
measure: Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall
timeFrame: Up to 15 months
measure: Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken
timeFrame: Up to 15 Months
measure: Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute
state: Michigan
city: Springfield
country: United States
facility: Clinvest Headlands Llc
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center ( WFUBMC )
state: North Carolina
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 - Sioux Falls
state: South Dakota
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Salt Lake City
country: United States
facility: Granger Medical Holladay - Holladay Clinic
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Edmonton
country: Canada
facility: University Of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Red Deer
country: Canada
facility: CaRe Clinic
state: Alberta
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Hradec Králové
city: Prague
country: Czechia
facility: Fakultni Thomayerova nemocnice
state: Praha 4
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole
state: Praha 5
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala
state: Pohjois-savo
city: Helsinki
country: Finland
facility: New Children's Hospital
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-suomi
city: Turku
country: Finland
facility: Terveystalo Pulssi
city: Nagykanizsa
country: Hungary
facility: Nagykanizsai Kanizsai Dorottya Korhaz
state: Zala
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Gurugram
country: India
facility: Artemis hospital
state: Haryana
city: Gurugram
country: India
facility: Fortis Memorial Research Institute
state: Haryana
city: Mangalore
country: India
facility: Mallikatta Neuro Centre
state: Karnataka
city: Mysore
country: India
facility: JSS Hospital
state: Karnataka
city: Nashik
country: India
facility: Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute
state: Maharashtra
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
state: Lazio
city: Milano
country: Italy
facility: IRCCS Istituto Neurologico Carlo Besta
state: Lombardia
city: Bari
country: Italy
facility: Ospedale San Paolo Bari
state: Puglia
city: Latina
country: Italy
facility: I.C.O.T. Università La Sapienza
city: Kobe
country: Japan
facility: Konan Medical Center
state: Hyogo
city: Nishinomiya
country: Japan
facility: Yamaguchi Clinic
state: Hyōgo
city: Osaka-Shi
country: Japan
facility: Tominaga Clinic
state: Osaka
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic
state: Tokyo
city: Kai
country: Japan
facility: Nagaseki Headache Clinic
state: Yamanashi
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgery&Headache Clinic
city: Osaka
country: Japan
facility: Tennoji Department of Neurosurgery
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny
state: Dolnośląskie
city: Wroclaw
country: Poland
facility: MedicArt Sp. z o. o.
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: AthleticoMed
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Centrum Medyczne Hope Clinic Sebastian Szklener
state: Lubelskie
city: Warsaw
country: Poland
facility: Neurosphera
state: Mazowieckie
city: Warsaw
country: Poland
facility: Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
state: Mazowieckie
city: Kraków
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o.
state: Małopolskie
city: Banská Bystrica
country: Slovakia
facility: Detska fakultna nemocnica s poliklinikou Banska Bystrica
city: Bardejov
country: Slovakia
facility: IN MEDIC s.r.o.
city: Bratislava
country: Slovakia
facility: Detsky neurolog s.r.o.
city: Dubnica nad Vahom
country: Slovakia
facility: KONZILIUM s.r.o.
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [barcelona]
city: Madrid
country: Spain
facility: Hospital Universitario HM Puerta del Sur
state: Madrid, Comunidad DE
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Vigo
country: Spain
facility: CHUVI- Hospital Alvaro Cunqueiro
state: Pontevedra
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: