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: March 25, 2004 Last Updated: August 14, 2009 History of Changes

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

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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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Outcome Measures

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1. Primary:

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

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2. Primary:

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

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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
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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