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

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Conditions:	Excessive Sleepiness Shift Work Sleep Disorder
Interventions:	Drug: Armodafinil 150 mg/day Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
42 centers (37 in US, 5 in Canada). First patient enrolled: 2 April 2004/ Last patient last visit: 23 December 2004

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
9 participants (3 female ; 6 male) withdrew after randomization but prior to receiving study drug

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Armodafinil 150 mg/Day	Placebo
STARTED	127	127
COMPLETED	97	89
NOT COMPLETED	30	38
Adverse Event	7	4
Lost to Follow-up	3	5
Physician Decision	6	2
Withdrawal by Subject	3	16
Miscellaneous	11	11

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Armodafinil 150 mg/Day	Placebo	Total
Number of Participants [units: participants]	127	127	254
Age^[1] [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	123	122	245
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	38.9 ± 10.75	40.3 ± 10.76	39.6 ± 10.76
Gender^[2] [units: participants]
Female	57	58	115
Male	66	64	130
Region of Enrollment [units: participants]
United States	117	117	234
Canada	10	10	20

[1]	9 participants (3 female ; 6 male) withdrew after randomization but prior to receiving study drug
[2]	9 participants (3 female ; 6 male) withdrew after randomization but prior to receiving study drug

Outcome Measures

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1. Primary:

Multiple Sleep Latency Test (MSLT) [ up to 12 weeks ]

Measure Type	Primary
Measure Title	Multiple Sleep Latency Test (MSLT)
Measure Description	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).
Time Frame	up to 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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.

Reporting Groups

	Description
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

Measured Values

	Armodafinil 150 mg/Day	Placebo
Number of Participants Analyzed [units: participants]	112	104
Multiple Sleep Latency Test (MSLT) [units: Minutes] Mean ± Standard Deviation	3.1 ± 4.46	0.4 ± 2.87

Statistical Analysis 1 for Multiple Sleep Latency Test (MSLT)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001
Mean Difference (Final Values) ^[4]	2.7
95% Confidence Interval	( 1.67 to 3.69 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

2. Primary:

Clinical Global Impression of Change (CGI-C) [ up to 12 weeks ]

Measure Type	Primary
Measure Title	Clinical Global Impression of Change (CGI-C)
Measure Description	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.
Time Frame	up to 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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.

Reporting Groups

	Description
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

Measured Values

	Armodafinil 150 mg/Day	Placebo
Number of Participants Analyzed [units: participants]	112	104
Clinical Global Impression of Change (CGI-C) [units: Participants]	112	104

Statistical Analysis 1 for Clinical Global Impression of Change (CGI-C)

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.0010

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The p value for each treatment group is for the comparison of that treatment group to the placebo treatment group. Adjusted for country.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Sponsor's Medical Director, Clinical Research
Organization: Cephalon
phone: 1-877-237-4879

No publications provided

Study ID Numbers:	C10953/3022/CM/MN
Study First Received:	March 25, 2004
Results First Received:	June 1, 2009
Last Updated:	August 14, 2009
ClinicalTrials.gov Identifier:	NCT00080288 History of Changes
Health Authority:	United States: Food and Drug Administration