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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Rimegepant 75 mg orally disintegrating tablets
Matching placebo oral disintegrating tablets
Adult & Child Neurology Medical Associates
Long Beach, California, United States
RECRUITINGAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGChicago Headache Center and Research Institute
Chicago, Illinois, United States
NOT_YET_RECRUITINGChicago Headache Center and Research Institute
Naperville, Illinois, United States
Number of migraine days per month
Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month
Time frame: 12 Weeks
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month
Change in the use of acute migraine-specific medication days per month
Time frame: 12 Weeks
Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month
Change in headache days per month
Time frame: 12 Weeks
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
Change in moderate or severe migraine days per month
Time frame: 12 weeks
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score
Change in the Quality of Life
Time frame: 12 Weeks
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
Change in headache and migraine rescue medication(s) used
Time frame: 12 Weeks
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
Safety and tolerability of the study drug
Time frame: Up to 15 months
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
Safety monitoring of adverse events of special interest
Time frame: Up to 15 Months
Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score
Change in the Quality of Life
Time frame: 12 Weeks
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New England Regional Headache Center
Worcester, Massachusetts, United States
RECRUITINGMichigan Headache & Neurological Institute
Ann Arbor, Michigan, United States
RECRUITINGClinvest Headlands Llc
Springfield, Missouri, United States
RECRUITINGRutgers University
New Brunswick, New Jersey, United States
RECRUITINGOnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States
RECRUITINGOnSite Clinical Solutions
Charlotte, North Carolina, United States
RECRUITING...and 96 more locations