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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00107848 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Narcolepsy Sleep Apnea, Obstructive |
Drug: Modafinil |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| Official Title: | 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 |
| 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.
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 61 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00107848 History of Changes |
| Other Study ID Numbers: | C1538/3029/ES/MN-Open label |
| Study First Received: | April 8, 2005 |
| Last Updated: | September 7, 2007 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Pediatric Narcolepsy Pediatric OSA CPAP Pediatric Narcolepsy or OSAHS |
|
Apnea Narcolepsy Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |