Clinical Trial: Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Adol
Brief 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).
Detailed Summary:
Sponsor: Cephalon
Current Primary Outcome:
- 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)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical Global Impression of Change (CGI-C) ratings for ES at weeks 3 and 6
- Total score from the Pediatric Daytime Sleepiness Scale (PDSS) at weeks 3 and 6, and last postbaseline observation
- Mean sleep latency from the MSLT (average of 4 naps performed at 0900, 1100, 1300, and 1500) at week 6
Original Secondary Outcome: Same as current
Information By: Teva Pharmaceutical Industries
Dates:
Date Received: April 8, 2005
Date Started: October 2004
Date Completion: September 2005
Last Updated: August 22, 2012
Last Verified: May 2006
