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

Phase 3
Recruiting
Conditions
Interventions
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.
...

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
200
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RimegepantRimegepantExperimental medicine under study
PlaceboPlaceboA placebo does not have any medicine in it but looks just like the medicine being studied.
Primary Outcome Measures
NameTimeMethod
Number of migraine days per month12 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
NameTimeMethod
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month12 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 month12 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 month12 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 score12 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 month12 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 overallUp 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 takenUp 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 score12 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

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