Narcolepsy Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of PROVIGIL ® (Modafinil) Treatment (100, 200, and 400 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness
of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with
excessive sleepiness (ES) associated with narcolepsy, as assessed by:
- mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps
performed at 0900, 1100, 1300, and 1500) at the last post-baseline observation (week 6
or early termination)
- the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last
post-baseline observation (week 6 or early termination).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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