Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
This study has been completed.
First Posted: September 22, 2005
Last Update Posted: May 31, 2012
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
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 obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries ( Cephalon ):
Primary Outcome Measures:
- Adverse event evaluations [ Time Frame: up to 6 months ]Evaluate the safety and tolerability of treatment in children and adolescents with excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea/hypopnea syndrome, when administered for up to 6 months
Secondary Outcome Measures:
- Composite Ratings of severity of illness [ Time Frame: up to 6 months ]Clinical global impression (CGI-C) ratings for severity of illness. The ratings range from 1 to 7; 1 =normal-not at all ill to 7 =among the most extremely ill.
- Total score from the Pediatric Daytime Sleepiness Scale (PDSS) [ Time Frame: up to 6 months ]A measure of daytime sleepiness and school-related outcomes using PDSS questions: This self-report 8-item questionnaire asks questions with ranges from Always to Never; always being the worst case and never the best case.
|Study Start Date:||January 2005|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
Subjects began taking Provigil at a dosage of 100 mg/day (1 tablet) and increased their dosage by 100 mg/day each week for up to 4 weeks
maximum dosage 400 mg/day (4 tablets)
Other Name: Provigil
Contacts and Locations
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