Trials / Completed
CompletedNCT00214968
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Cephalon · Industry
- Sex
- All
- Age
- 6 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Modafinil | maximum dosage 400 mg/day (4 tablets) |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2005-10-01
- Completion
- 2005-10-01
- First posted
- 2005-09-22
- Last updated
- 2012-05-31
Source: ClinicalTrials.gov record NCT00214968. Inclusion in this directory is not an endorsement.