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| Sponsored by: |
Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00214968 |
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 obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Excessive Daytime Sleepiness Narcolepsy |
Drug: PROVIGIL (modafinil) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| 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 |
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusions Criteria:
Exclusion Criteria: Patients are excluded for participating in this if 1 or more of the following criteria are met:
Contacts and Locations
Show 32 Study Locations
More Information
| Study ID Numbers: | C1538/3034/ES/MN |
| Study First Received: | September 14, 2005 |
| Last Updated: | April 20, 2006 |
| ClinicalTrials.gov Identifier: | NCT00214968 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sleep Apnea Syndromes Apnea Sleep Apnea, Obstructive Sleep Disorders Dyssomnias Central Nervous System Stimulants Disorders of Excessive Somnolence |
Neuroprotective Agents Modafinil Sleep Disorders, Intrinsic Narcolepsy Mental Disorders Gelineau's Syndrome |
|
Nervous System Diseases Physiological Effects of Drugs Dyssomnias Sleep Disorders Central Nervous System Stimulants Disorders of Excessive Somnolence Protective Agents Neuroprotective Agents |
Modafinil Pharmacologic Actions Sleep Disorders, Intrinsic Narcolepsy Mental Disorders Therapeutic Uses Central Nervous System Agents |