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NCT00107809 · ClinicalTrials.gov registry record · Phase 3
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
A Phase 3 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
NCT00107809 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 140 participants.
The verdict
NCT00107809, a Phase 3 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
Study Summary
The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by: * mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6 or early termination) * the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post baseline observation (week 6 or early termination).
Interventions
- DRUG Modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2004-10 |
| Est. Completion | 2005-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00107809
The ClinicalTrials.gov registry entry for NCT00107809 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Modafinil is the first listed.
NCT00107809 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00107809 about?
NCT00107809 is a clinical study titled "Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome". The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by: * mean sleep latency from the Mu...
What is the current status of trial NCT00107809?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2004-10. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00107809?
The interventions under investigation include: Modafinil (DRUG).
Who is sponsoring clinical trial NCT00107809?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
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