The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
640
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Reduction from baseline in mean number of migraine days per month
Time frame: 3 months (12 weeks)
Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine
Time frame: 3 months (12 weeks)
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
Time frame: Weeks 1 through 4 of treatment
The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Time frame: Total score at week 12
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Time frame: 3 months (12 weeks)
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.
Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Time frame: 3 months (12 weeks)
Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.
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The Belinga Clinic
Fort Smith, Arkansas, United States
ACTIVE_NOT_RECRUITINGAdvanced Investigative Medicine, Inc.
Hawthorne, California, United States
RECRUITINGVelocity Clinical Research San Diego
La Mesa, California, United States
ACTIVE_NOT_RECRUITINGColorado Springs Neurological Associates
Colorado Springs, Colorado, United States
ACTIVE_NOT_RECRUITINGAdvanced Neurosciences Research, LLC
Fort Collins, Colorado, United States
TERMINATEDMeridian Clinical Research, LLC
Washington D.C., District of Columbia, United States
RECRUITINGAccel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, United States
ACTIVE_NOT_RECRUITINGDirect Helpers Research Center
Hialeah, Florida, United States
RECRUITINGNew Med Research, Inc
Hollywood, Florida, United States
TERMINATEDComplete Health Research
Ormond Beach, Florida, United States
ACTIVE_NOT_RECRUITING...and 81 more locations
Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
Time frame: 3 months (12 weeks)
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.
This will be evaluated by the number of subjects with treatment related adverse events by severity.
Time frame: 72 Weeks
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.
Measured by discontinuations in treated subjects due to elevated liver function tests.
Time frame: 72 Weeks