|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00107809 |
Purpose
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive |
Drug: Modafinil |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of PROVIGIL ® (Modafinil) Treatment (100, 200, and 400 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome |
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | September 2005 |
PROVIGIL is a trademark of Genelco, SA, 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:
Meet the minimal criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for OSAHS as assessed by all of the following: *clinical history;
*have a previous diagnosis of OSAHS on the basis of NPSG (nocturnal polysomnogram) and/or MSLT at any time before the screening visit. If the patient is a current user of CPAP (continuous positive airway pressure) therapy and is appropriately titrated on CPAP, the AHI ≥5 inclusion criterion is not applicable; *NPSG (nocturnal polysomnogram) (as evaluated by the investigator) to rule out other sleep disorders (ie, narcolepsy and periodic limb movement with sleep [PLMs]).
Exclusion Criteria:
Contacts and Locations
Show 64 Study Locations
More Information
| Study ID Numbers: | C1538/3028/AP/MN-OSAHS |
| Study First Received: | April 8, 2005 |
| Last Updated: | October 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00107809 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Health Canada: |
|
Pediatric Obstructive sleep Apnea Excessive sleepiness CPAP Pediatric OSAHS |
|
Sleep Apnea Syndromes Apnea Physiological Effects of Drugs Sleep Apnea, Obstructive Respiration Disorders Nervous System Diseases Dyssomnias Sleep Disorders Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Pharmacologic Actions Modafinil Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Therapeutic Uses Signs and Symptoms, Respiratory Central Nervous System Agents |