Trial Outcomes & Findings for Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy (NCT NCT00078377)

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

196 participants

Primary outcome timeframe

change from baseline at 12 weeks

Results posted on

2013-07-19

Participant Flow

47 centers in the US, Canada, France, Germany, Russia, and Australia. First patient enrolled (treatment): 23 March 2004/ Last patient last visit: 10 January 2005

2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was 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 in the morning
Overall Study STARTED	67	65	64
Overall Study COMPLETED	56	49	55
Overall Study NOT COMPLETED	11	16	9

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 in the morning
Overall Study Adverse Event	2	5	1
Overall Study Lack of Efficacy	2	0	2
Overall Study Lost to Follow-up	0	1	1
Overall Study Physician Decision	2	0	0
Overall Study Withdrawal by Subject	3	4	4
Overall Study Miscellaneous	2	6	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil 250 mg/Day n=67 Participants Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=65 Participants Armodafinil 150 mg once daily in the morning	Placebo n=64 Participants Matching placebo tablets once daily in the morning	Total n=196 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	0 participants n=4 Participants
Age Categorical Between 18 and 65 years	66 participants n=5 Participants	64 participants n=7 Participants	63 participants n=5 Participants	193 participants n=4 Participants
Age Categorical >=65 years	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Age Continuous	35.0 years STANDARD_DEVIATION 12.52 • n=5 Participants	40.4 years STANDARD_DEVIATION 12.52 • n=7 Participants	39.2 years STANDARD_DEVIATION 11.98 • n=5 Participants	38.1 years STANDARD_DEVIATION 12.50 • n=4 Participants
Gender Female	42 participants n=5 Participants	36 participants n=7 Participants	31 participants n=5 Participants	109 participants n=4 Participants
Gender Male	25 participants n=5 Participants	28 participants n=7 Participants	32 participants n=5 Participants	85 participants n=4 Participants
Region of Enrollment United States	37 participants n=5 Participants	37 participants n=7 Participants	37 participants n=5 Participants	111 participants n=4 Participants
Region of Enrollment Canada	12 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	36 participants n=4 Participants
Region of Enrollment France	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	9 participants n=4 Participants
Region of Enrollment Germany	5 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment Russian Federation	5 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment Australia	5 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants

PRIMARY outcome

Timeframe: change from baseline at 12 weeks

Population: Safety Analysis set of 194 total patients: 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up). Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy.

Outcome measures

Outcome measures
Measure	Armodafinil 250 mg/Day n=60 Participants Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=58 Participants Armodafinil 150 mg once daily in the morning	Placebo n=58 Participants Matching placebo tablets once daily in the morning	Armodafinil Combined Group (250 mg/Day and 150 mg/Day) n=118 Participants
Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks	2.6 Minutes Standard Deviation 6.24	1.3 Minutes Standard Deviation 6.31	-1.9 Minutes Standard Deviation 6.87	1.9 Minutes Standard Deviation 6.28

PRIMARY outcome

Timeframe: change from baseline at 12 weeks

Population: Safety Analysis set of 194 total patients (received at least 1 dose of study drug): 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up). Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy analysis.

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 250 mg/Day n=60 Participants Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=58 Participants Armodafinil 150 mg once daily in the morning	Placebo n=58 Participants Matching placebo tablets once daily in the morning	Armodafinil Combined Group (250 mg/Day and 150 mg/Day) n=118 Participants
Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks	60 Participants	58 Participants	58 Participants	118 Participants

Adverse Events

Armodafinil 250 mg/Day

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Armodafinil 150 mg/Day

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Armodafinil 250 mg/Day n=67 participants at risk Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=64 participants at risk Armodafinil 150 mg once daily in the morning	Placebo n=63 participants at risk Matching placebo tablets once daily in the morning
Skin and subcutaneous tissue disorders Angioneurotic oedema	0.00% 0/67	1.6% 1/64	0.00% 0/63

Other adverse events

Other adverse events
Measure	Armodafinil 250 mg/Day n=67 participants at risk Armodafinil 250 mg once daily in the morning	Armodafinil 150 mg/Day n=64 participants at risk Armodafinil 150 mg once daily in the morning	Placebo n=63 participants at risk Matching placebo tablets once daily in the morning
Gastrointestinal disorders Nausea	7.5% 5/67	14.1% 9/64	0.00% 0/63
Infections and infestations Nasopharyngitis	4.5% 3/67	3.1% 2/64	7.9% 5/63
Metabolism and nutrition disorders Decreased appetite	6.0% 4/67	3.1% 2/64	0.00% 0/63
Nervous system disorders Headache	28.4% 19/67	15.6% 10/64	11.1% 7/63
Nervous system disorders Dizziness	3.0% 2/67	7.8% 5/64	0.00% 0/63

Additional Information

Sponsor's Medical Director, Clinical Research

Cephalon, Inc.

Phone: 1-877-237-4879

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60