Trial Outcomes & Findings for Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome (NCT NCT00079677)

Last Updated: 2013-07-19

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

263 participants

Primary outcome timeframe

Change from baseline at 12 weeks or early termination

Results posted on

2013-07-19

Participant Flow

36 centers in the United States, France, Germany, Russia, and Australia. First participant enrolled: 26 March 2004/ Last participant last visit: 23 October 2004

Participant milestones

Participant milestones
Measure	Armodafinil 150 mg/Day Armodafinil 150 mg once daily in the morning	Placebo Matching placebo tablets once daily
Overall Study STARTED	131	132
Overall Study COMPLETED	111	118
Overall Study NOT COMPLETED	20	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Armodafinil 150 mg/Day Armodafinil 150 mg once daily in the morning	Placebo Matching placebo tablets once daily
Overall Study Adverse Event	5	6
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	2	2
Overall Study Physician Decision	3	0
Overall Study Protocol Violation	2	3
Overall Study Withdrawal by Subject	5	3
Overall Study Miscellaneous	2	0

Baseline Characteristics

Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil 150 mg/Day n=131 Participants Armodafinil 150 mg once daily in the morning	Placebo n=132 Participants Matching placebo tablets once daily	Total n=263 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	127 participants n=5 Participants	129 participants n=7 Participants	256 participants n=5 Participants
Age Categorical >=65 years	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Age Continuous	50.7 years STANDARD_DEVIATION 9.17 • n=5 Participants	50.6 years STANDARD_DEVIATION 8.85 • n=7 Participants	50.7 years STANDARD_DEVIATION 8.99 • n=5 Participants
Gender Female	32 participants n=5 Participants	37 participants n=7 Participants	69 participants n=5 Participants
Gender Male	97 participants n=5 Participants	93 participants n=7 Participants	190 participants n=5 Participants
Region of Enrollment United States	99 participants n=5 Participants	99 participants n=7 Participants	198 participants n=5 Participants
Region of Enrollment France	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Germany	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Russian Federation	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Australia	20 participants n=5 Participants	21 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline at 12 weeks or early termination

Population: Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug. Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy.

Outcome measures

Outcome measures
Measure	Armodafinil 150 mg/Day n=116 Participants Armodafinil 150 mg once daily in the morning	Placebo n=120 Participants Matching placebo tablets once daily
Maintenance of Wakefulness Test (MWT)	2.3 Minutes Standard Deviation 7.80	-1.3 Minutes Standard Deviation 7.08

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Armodafinil 150 mg/Day n=116 Participants Armodafinil 150 mg once daily in the morning	Placebo n=120 Participants Matching placebo tablets once daily
Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.	82 Participants	64 Participants

Adverse Events

Armodafinil 150 mg/Day

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Armodafinil 150 mg/Day n=129 participants at risk Armodafinil 150 mg once daily in the morning	Placebo n=130 participants at risk Matching placebo tablets once daily
Gastrointestinal disorders Gastro-oesophageal reflux disease	0.00% 0/129	0.77% 1/130

Other adverse events

Other adverse events
Measure	Armodafinil 150 mg/Day n=129 participants at risk Armodafinil 150 mg once daily in the morning	Placebo n=130 participants at risk Matching placebo tablets once daily
Infections and infestations Upper respiratory tract infection	3.9% 5/129	6.2% 8/130
Nervous system disorders Headache	14.7% 19/129	6.9% 9/130

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