Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy

Phase 3

Completed

• Conditions: Narcolepsy
• Interventions: Drug: Placebo; Drug: Armodafinil

• Registration Number: NCT00078377
• Lead Sponsor: Cephalon

Brief Summary

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 narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline observation)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-02-24
• Study First Submitted QC: 2004-02-25
• Study First Posted: 2004-02-26
• Study Start: 2004-03
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Results First Submitted: 2009-06-01
• Results First Submitted QC: 2009-12-17
• Results First Posted: 2010-01-21
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	Placebo
1	Armodafinil	Armodafinil 250 mg
2	Armodafinil	Armodafinil 150 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks	change from baseline at 12 weeks	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).
Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks	change from baseline at 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.