Who is sponsoring NCT00079677?

NCT00079677 is sponsored by Cephalon.

What condition does NCT00079677 study?

NCT00079677 studies Obstructive Sleep Apnea, Sleep Hypopnea.

What drugs are being tested in NCT00079677?

Interventions: Armodafinil 150 mg/day, Placebo.

What is the status of NCT00079677?

NCT00079677 is currently COMPLETED.

Last reviewed 2013-07-12 · How we verify

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome

NCT00079677 Phase 3 COMPLETED Results posted

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

Details

Lead sponsor	Cephalon
Phase	Phase 3
Status	COMPLETED
Enrolment	263
Start date	2004-03
Completion	2004-10

Conditions

Obstructive Sleep Apnea
Sleep Hypopnea

Interventions

Armodafinil 150 mg/day
Placebo

Primary outcomes

Maintenance of Wakefulness Test (MWT) — Change from baseline at 12 weeks or early termination
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).
Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit. — 12 weeks or last post-baseline visit
Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.