Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
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|ClinicalTrials.gov Identifier: NCT00080288|
Recruitment Status : Completed
First Posted : March 29, 2004
Results First Posted : September 23, 2009
Last Update Posted : July 19, 2013
Information provided by:
Teva Pharmaceutical Industries
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.
|Condition or disease||Intervention/treatment||Phase|
|Excessive Sleepiness Shift Work Sleep Disorder||Drug: Armodafinil 150 mg/day Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 mg) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder|
|Study Start Date :||March 2004|
|Study Completion Date :||December 2004|
Armodafinil 150 mg/day
Drug: Armodafinil 150 mg/day
Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked.
Placebo Comparator: 2
Matching placebo tablets once daily
Primary Outcome Measures :
- Multiple Sleep Latency Test (MSLT) [ Time Frame: up to 12 weeks ]The Multiple Sleep Latency Test (MSLT) 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. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit).
- Clinical Global Impression of Change (CGI-C) [ Time Frame: up to 12 weeks ]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.
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