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

This study has been completed.

Study NCT00078377 Information provided by Cephalon

First Received on February 24, 2004. Last Updated on December 17, 2009 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
Condition:	Narcolepsy
Interventions:	Drug: Armodafinil 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
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

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up)

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Armodafinil 250 mg/Day	Armodafinil 150 mg/Day	Placebo
STARTED	67	65	64
COMPLETED	56	49	55
NOT COMPLETED	11	16	9
Adverse Event	2	5	1
Lack of Efficacy	2	0	2
Lost to Follow-up	0	1	1
Physician Decision	2	0	0
Withdrawal by Subject	3	4	4
Miscellaneous	2	6	1

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Armodafinil 250 mg/Day	Armodafinil 150 mg/Day	Placebo	Total
Number of Participants [units: participants]	67	65	64	196
Age ^[1] [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	66	64	63	193
>=65 years	1	0	0	1
Age [units: years] Mean ± Standard Deviation	35.0 ± 12.52	40.4 ± 12.52	39.2 ± 11.98	38.1 ± 12.50
Gender ^[1] [units: participants]
Female	42	36	31	109
Male	25	28	32	85
Region of Enrollment [units: participants]
United States	37	37	37	111
Canada	12	12	12	36
France	3	3	3	9
Germany	5	4	4	13
Russian Federation	5	4	4	13
Australia	5	5	4	14

[1]	2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up)

Outcome Measures

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1. Primary:

Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks [ Time Frame: change from baseline at 12 weeks ]

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2. Primary:

Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks [ Time Frame: change from baseline at 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
No text entered.

Results Point of Contact:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00078377 History of Changes
Other Study ID Numbers:	C10953/3020/NA/MN
Study First Received:	February 24, 2004
Results First Received:	June 1, 2009
Last Updated:	December 17, 2009
Health Authority:	United States: Food and Drug Administration