A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
- Registration Number
- NCT06616194
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rimegepant Rimegepant Experimental medicine under study Placebo Placebo A placebo does not have any medicine in it but looks just like the medicine being studied.
- Primary Outcome Measures
Name Time Method Number of migraine days per month 12 Weeks Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month
- Secondary Outcome Measures
Name Time Method Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month 12 Weeks Change in the use of acute migraine-specific medication days per month
Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month 12 Weeks Change in headache days per month
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 12 weeks Change in moderate or severe migraine days per month
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score 12 Weeks Change in the Quality of Life
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 12 Weeks Change in headache and migraine rescue medication(s) used
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 Up to 15 months Safety and tolerability of the study drug
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 Up to 15 Months Safety monitoring of adverse events of special interest
Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score 12 Weeks Change in the Quality of Life
Trial Locations
- Locations (42)
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
University Of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Fakultni Thomayerova nemocnice
🇨🇿Prague, Praha 4, Czechia
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Pirkanmaa, Finland
Nagykanizsai Kanizsai Dorottya Korhaz
🇭🇺Nagykanizsa, Zala, Hungary
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Fortis Memorial Research Institute
🇮🇳Gurugram, Haryana, India
JSS Hospital
🇮🇳Mysore, Karnataka, India
Ospedale San Paolo Bari
🇮🇹Bari, Puglia, Italy
MIGRE Polskie Centrum Leczenia Migreny
🇵🇱Wroclaw, Dolnośląskie, Poland
AthleticoMed
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Specjalistyczne Gabinety Sp. z o.o.
🇵🇱Kraków, Małopolskie, Poland
IN MEDIC s.r.o.
🇸🇰Bardejov, Slovakia
KONZILIUM s.r.o.
🇸🇰Dubnica nad Vahom, Slovakia
Hospital Universitario HM Puerta del Sur
🇪🇸Madrid, Madrid, Comunidad DE, Spain
CHUVI- Hospital Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra [pontevedra], Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, Spain
Michigan Headache & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Clinvest Headlands Llc
🇺🇸Springfield, Missouri, United States
Rutgers University
🇺🇸New Brunswick, New Jersey, United States
Wake Forest University Baptist Medical Center ( WFUBMC )
🇺🇸Winston-Salem, North Carolina, United States
Avera Medical Group Pediatric Specialists
🇺🇸Sioux Falls, South Dakota, United States
Avera Research Institute - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States
Granger Medical Holladay - Holladay Clinic
🇺🇸Salt Lake City, Utah, United States
CaRe Clinic
🇨🇦Red Deer, Alberta, Canada
Artemis hospital
🇮🇳Gurugram, Haryana, India
Mallikatta Neuro Centre
🇮🇳Mangalore, Karnataka, India
Konan Medical Center
🇯🇵Kobe, Hyogo, Japan
Yamaguchi Clinic
🇯🇵Nishinomiya, Hyōgo, Japan
Tominaga Clinic
🇯🇵Osaka-Shi, Osaka, Japan
Tokyo Headache Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Nagaseki Headache Clinic
🇯🇵Kai, Yamanashi, Japan
Tanaka Neurosurgery&Headache Clinic
🇯🇵Kagoshima, Japan
Tennoji Department of Neurosurgery
🇯🇵Osaka, Japan