RecruitingPhase 3NCT04743141
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
Sponsor
Pfizer
Enrollment
600 participants
Start Date
Apr 28, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
Eligibility
Min Age: 6 YearsMax Age: 17 Years
Inclusion Criteria8
- 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 screening.
- 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 Screening Visit.
- Ability to distinguish between migraine and other types of headaches.
- Weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25kg.
- Adequate venous access for blood sampling.
- Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
Exclusion Criteria7
- 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 at risk of self-harm/harm to others.
- History of major psychiatric disorder.
- Current diagnosis or history of substance abuse
- Reported current use of or tested positive at Screening for drugs of abuse.
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Interventions
DRUGRimegepant (PF-07899801)
Rimegepant 75 mg, 50 mg or 35 mg ODT
Locations(126)
View Full Details on ClinicalTrials.gov
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NCT04743141