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

This study has been completed.

Study NCT00080288 Information provided by Cephalon

First Received on March 25, 2004. Last Updated on May 14, 2010 History of Changes

Results First Received: June 1, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Conditions:	Excessive Sleepiness Shift Work Sleep Disorder
Interventions:	Drug: Armodafinil 150 mg/day Drug: Placebo

Participant Flow

Hide 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. These 9 patients are included in the Participant Flow table below.

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

Hide Baseline Characteristics

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 ^[1] [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

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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

ClinicalTrials.gov Identifier:	NCT00080288 History of Changes
Other Study ID Numbers:	C10953/3022/CM/MN
Study First Received:	March 25, 2004
Results First Received:	June 1, 2009
Last Updated:	May 14, 2010
Health Authority:	United States: Food and Drug Administration