A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

JRCT ID: jRCT2051240163

Registered date:16/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Migraine
• Date of first enrollment: 11/11/2024
• Target sample size: 200
• Study type: Interventional

Intervention(s)

-Rimegepant 75 mg orally disintegrating tablets
-Matching placebo oral disintegrating tablets

Outcome(s)

Primary Outcome

*Number of migraine days per month [Time Frame: 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

*Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 (PedsQLTM) total score [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 12 Weeks]
-Change in the Quality of Life

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 17age old
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT06616194