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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of Age. Estudio aleatorizado...

Update Il y a 4 ans
Reference: EUCTR2005-001234-32

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of Age. Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de topiramato en la profilaxis de la migraña en población pediátrica de 12 a 17 años de edad

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Extract

The objective of this study are to evaluate the efficacy of 2 dosages of topiramate, 50 and 100 mg/day, compared with placebo in the prevention of migraine attacks in subjects 12 to 17 years of age, as assessed by the percent reduction in the frequency of monthly migraine attacks over the last 12 weeks of the double-blind phase compared with baseline

Inclusion criteria

  • Migraine in Pediatric Population (12-17 year olds, inclusive)

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