Migraine Disorders Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of SPN-538 as a Therapy for the Prevention of Migraine in Subjects Ages 6-11 Years
The aim of this study is to evaluate the effect of SPN-538 for the prophylaxis of migraine in pediatric patients 6 to 11 years old.
The study is to assess the efficacy and safety of SPN-538 in reducing the monthly migraine headache frequency in pediatric patients with migraine. SPN-538 (or matching placebo) will be administered in patients diagnosed with migraine with or without aura based on the International Headache Society criteria. The frequency of the migraine attack will be assessed as the primary outcome measure. ;
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