Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
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).