A 6-Month Open Label, Flexible Dosage Study to Assess the Safety and Effectiveness of PROVIGIL Modafinil Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

• Conditions: Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome; MedDRA version: 6.1Level: HLGTClassification code 10040998

• Registration Number: EUCTR2004-002505-74-IT
• Lead Sponsor: CEPHALON EUROPE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ;Secondary Objective: ;Primary end point(s):