NCT00107809

Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome

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 Obstructive Sleep Apnea/Hypopnea Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (planned)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

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 obstructive sleep apnea/hypopnea syndrome (OSAHS), 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 description

PROVIGIL is a trademark of Genelco, SA, licensed to Cephalon, Inc.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DRUG	Modafinil

Timeline

• Start date: 2004-10-01
• Completion: 2005-09-01
• First posted: 2005-04-11
• Last updated: 2014-05-09

Locations

64 sites across 2 countries: United States, Canada