Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
Acute Treatment of Migraine
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of age).
History of migraine (with or without aura) for ≥ 6 months before Screening
History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment.
1 or more migraine days requiring treatment during the Observation Phase.
Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit
Ability to distinguish between migraine and other types of headaches.
Weight ≥ 40 kg at the Screening Visit.
Adequate venous access for blood sampling.
Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study)
History of cluster headache or hemiplegic migraine headache.
Confounding and clinically significant pain syndrome
Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
History of suicidal behavior or major psychiatric disorder.
Current diagnosis or history of substance abuse; positive drug test at Screening.