Trial Outcomes & Findings for Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD (NCT NCT00080288)

Last Updated: 2013-07-19

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

254 participants

Primary outcome timeframe

up to 12 weeks

Results posted on

2013-07-19

Participant Flow

42 centers (37 in US, 5 in Canada). First patient enrolled: 2 April 2004/ Last patient last visit: 23 December 2004

9 participants (3 female ; 6 male) withdrew after randomization but prior to receiving study drug. These 9 patients are included in the Participant Flow table below.

Participant milestones

Participant milestones
Measure	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 Matching placebo tablets once daily
Overall Study STARTED	127	127
Overall Study COMPLETED	97	89
Overall Study NOT COMPLETED	30	38

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Matching placebo tablets once daily
Overall Study Adverse Event	7	4
Overall Study Lost to Follow-up	3	5
Overall Study Physician Decision	6	2
Overall Study Withdrawal by Subject	3	16
Overall Study Miscellaneous	11	11

Baseline Characteristics

Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil 150 mg/Day n=127 Participants 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 n=127 Participants Matching placebo tablets once daily	Total n=254 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	123 participants n=5 Participants	122 participants n=7 Participants	245 participants n=5 Participants
Age Categorical >=65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age Continuous	38.9 years STANDARD_DEVIATION 10.75 • n=5 Participants	40.3 years STANDARD_DEVIATION 10.76 • n=7 Participants	39.6 years STANDARD_DEVIATION 10.76 • n=5 Participants
Gender Female	57 participants n=5 Participants	58 participants n=7 Participants	115 participants n=5 Participants
Gender Male	66 participants n=5 Participants	64 participants n=7 Participants	130 participants n=5 Participants
Region of Enrollment United States	117 participants n=5 Participants	117 participants n=7 Participants	234 participants n=5 Participants
Region of Enrollment Canada	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Population: Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy.

Outcome measures

Outcome measures
Measure	Armodafinil 150 mg/Day n=112 Participants 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 n=104 Participants Matching placebo tablets once daily
Multiple Sleep Latency Test (MSLT)	3.1 Minutes Standard Deviation 4.46	0.4 Minutes Standard Deviation 2.87

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Armodafinil 150 mg/Day n=112 Participants 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 n=104 Participants Matching placebo tablets once daily
Clinical Global Impression of Change (CGI-C)	112 Participants	104 Participants

Adverse Events

Armodafinil 150 mg/Day

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Armodafinil 150 mg/Day n=123 participants at risk 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 n=122 participants at risk Matching placebo tablets once daily
Infections and infestations Meningitis viral	0.81% 1/123	0.00% 0/122
Psychiatric disorders Depression suicidal	0.00% 0/123	0.82% 1/122

Other adverse events

Other adverse events
Measure	Armodafinil 150 mg/Day n=123 participants at risk 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 n=122 participants at risk Matching placebo tablets once daily
Gastrointestinal disorders Nausea	7.3% 9/123	3.3% 4/122
Infections and infestations Nasopharyngitis	5.7% 7/123	3.3% 4/122
Nervous system disorders Headache	12.2% 15/123	9.8% 12/122

Additional Information

Sponsor's Medical Director, Clinical Research

Cephalon

Phone: 1-877-237-4879

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60