Trial Outcomes & Findings for Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS) (NCT NCT00078325)

Last Updated: 2013-07-19

Results Overview

The 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 primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

395 participants

Primary outcome timeframe

change from baseline at 12 weeks

Results posted on

2013-07-19

Participant Flow

37 centers in the US and Canada. First patient enrolled: 19 February 2004/ Last patient last visit: 6 November 2004

3 female patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)

Participant milestones

Participant milestones
Measure	Armodafinil 250 mg/Day Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day Armodafinil 150 mg once daily in the morning	Placebo Matching placebo tablets once daily
Overall Study STARTED	131	133	131
Overall Study COMPLETED	110	114	120
Overall Study NOT COMPLETED	21	19	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Armodafinil 250 mg/Day Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day Armodafinil 150 mg once daily in the morning	Placebo Matching placebo tablets once daily
Overall Study Adverse Event	15	10	5
Overall Study Protocol Violation	2	2	0
Overall Study Withdrawal by Subject	1	5	3
Overall Study Lost to Follow-up	0	1	1
Overall Study Physician Decision	2	0	1
Overall Study Miscellaneous	1	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil 250 mg/Day n=131 Participants Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=131 Participants Armodafinil 150 mg once daily in the morning	Placebo n=130 Participants Matching placebo tablets once daily	Total n=392 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	130 Participants n=93 Participants	131 Participants n=4 Participants	129 Participants n=27 Participants	390 Participants n=483 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Age Continuous	49.1 years STANDARD_DEVIATION 8.74 • n=93 Participants	49.3 years STANDARD_DEVIATION 9.17 • n=4 Participants	50.1 years STANDARD_DEVIATION 9.43 • n=27 Participants	49.5 years STANDARD_DEVIATION 9.10 • n=483 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	34 Participants n=4 Participants	40 Participants n=27 Participants	116 Participants n=483 Participants
Sex: Female, Male Male	89 Participants n=93 Participants	97 Participants n=4 Participants	90 Participants n=27 Participants	276 Participants n=483 Participants
Region of Enrollment United States	117 participants n=93 Participants	119 participants n=4 Participants	117 participants n=27 Participants	353 participants n=483 Participants
Region of Enrollment Canada	14 participants n=93 Participants	14 participants n=4 Participants	14 participants n=27 Participants	42 participants n=483 Participants

PRIMARY outcome

Timeframe: change from baseline at 12 weeks

Population: Safety Analysis set of 392 total patients: 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up) Full Analysis set of 365 total patients: 27 patients that had withdrawn from the study were non-evaluable for efficacy.

Outcome measures

Outcome measures
Measure	Armodafinil 250 mg/Day n=121 Participants Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=120 Participants Armodafinil 150 mg once daily in the morning	Placebo n=124 Participants Matching placebo tablets once daily
Maintenance of Wakefulness Test (MWT)	2.2 Minutes Standard Deviation 8.07	1.7 Minutes Standard Deviation 6.49	-1.7 Minutes Standard Deviation 8.59

PRIMARY outcome

Timeframe: change from baseline at 12 weeks

Population: Safety Analysis set of 392 total patients (ITT): 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)

The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include: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 (CGI-S) was assessed at baseline includes categories: 1=Normal; 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 250 mg/Day n=121 Participants Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=120 Participants Armodafinil 150 mg once daily in the morning	Placebo n=124 Participants Matching placebo tablets once daily
Clinical Global Impression of Change (CGI-C)	121 Participants	120 Participants	124 Participants

Adverse Events

Armodafinil 250 mg/Day

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Armodafinil 150 mg/Day

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Armodafinil 250 mg/Day n=131 participants at risk Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=131 participants at risk Armodafinil 150 mg once daily in the morning	Placebo n=130 participants at risk Matching placebo tablets once daily
Gastrointestinal disorders Colitis ulcerative	0.76% 1/131	0.00% 0/131	0.00% 0/130
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/131	0.76% 1/131	0.00% 0/130
Nervous system disorders Migraine	0.00% 0/131	0.76% 1/131	0.00% 0/130
Psychiatric disorders Affective disorder	0.00% 0/131	0.76% 1/131	0.00% 0/130
Psychiatric disorders Personality disorder	0.00% 0/131	0.76% 1/131	0.00% 0/130

Other adverse events

Other adverse events
Measure	Armodafinil 250 mg/Day n=131 participants at risk Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=131 participants at risk Armodafinil 150 mg once daily in the morning	Placebo n=130 participants at risk Matching placebo tablets once daily
Gastrointestinal disorders Nausea	9.9% 13/131	2.3% 3/131	4.6% 6/130
Gastrointestinal disorders Dry Mouth	7.6% 10/131	0.76% 1/131	0.00% 0/130
Nervous system disorders Headache	20.6% 27/131	14.5% 19/131	8.5% 11/130
Nervous system disorders Dizziness	6.1% 8/131	3.8% 5/131	1.5% 2/130
Psychiatric disorders Insomnia	6.9% 9/131	6.1% 8/131	1.5% 2/130

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