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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 |
| MedlinePlus related topics: | Sleep Apnea |
| Drug Information available for: | Modafinil |
| 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 |
| Cephalon |
More Information
| Study ID Numbers: | C1538/3034/ES/MN |
| First Received: | September 14, 2005 |
| Last Updated: | April 20, 2006 |
| ClinicalTrials.gov Identifier: | NCT00214968 |
| Health Authority: | United States: Food and Drug Administration |
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