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.
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- 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 (11)
Tominaga Clinic
🇯🇵Osaka-Shi, Osaka, Japan
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States
Granger Medical Holladay - Holladay Clinic
🇺🇸Salt Lake City, Utah, United States
Michigan Headache & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Clinvest Headlands Llc
🇺🇸Springfield, Missouri, United States
Konan Medical Center
🇯🇵Kobe, Hyogo, Japan
Yamaguchi Clinic
🇯🇵Nishinomiya, Hyōgo, Japan
Tokyo Headache Clinic
🇯🇵Shubuya-ku, Tokyo, Japan
Nagaseki Headache Clinic
🇯🇵Kai, Yamanashi, Japan
Tanaka Neurosurgical Clinic
🇯🇵Kagoshima, Japan
Tennoji Department of Neurosurgery
🇯🇵Osaka, Japan