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NCT05156398
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Conditions: Migraine
Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 640
Sponsor: Pfizer
Location: The Belinga Clinic Fort Smith Arkansas
Summary
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 \
Eligibility Criteria
Inclusion Criteria:
1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
2. 6 or more migraine days during the Observation Period
3. 14 or less headache days during the Observation Period
4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \
Source: ClinicalTrials.gov (NCT05156398). StuddyBuddy aggregates publicly available trial information.