NCT00107848

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

A 1 Year Open Label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (planned)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep apnea/hypopnea), when administered for up to 12 months. Safety and tolerability will be evaluated throughout the study by means of adverse event information, clinical laboratory test results, vital signs measurements, and body weight and height measurements; quarterly physical examination findings; and 12 lead electrocardiograph (ECG) evaluations at the end of the study. In addition, the cognitive and behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior Checklist for Ages 6-18 (CBCL/6-18), a brief psychiatric interview, and the Kaufman Brief Intelligence Test (KBIT 2).

Detailed description

PROVIGIL is a registered trademark of Genelco, S.A., licensed to Cephalon, Inc.

Conditions

• Narcolepsy
• 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

61 sites across 2 countries: United States, Canada