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).
Primary Outcome Measures:
- 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, when administered for up to 12 months.
Secondary Outcome Measures:
- The secondary objective of the study is to evaluate long-term effectiveness by using: the Clinical Global Impression of Change (CGI C) ratings for severity of ES and the total score from the Pediatric Daytime Sleepiness Scale (PDSS)
| Estimated Enrollment: |
280 |
| Study Start Date: |
October 2004 |
| Estimated Study Completion Date: |
September 2005 |
PROVIGIL is a registered trademark of Genelco, S.A., licensed to Cephalon, Inc.