Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)

This study has been completed.

Study NCT00078325 Information provided by Cephalon

First Received on February 23, 2004. Last Updated on July 6, 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:	Obstructive Sleep Apnea Hypopnea
Interventions:	Drug: Armodafinil 250 mg/day 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
37 centers in the US and Canada. First patient enrolled: 19 February 2004/ Last patient last visit: 6 November 2004

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 female patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were 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

Participant Flow: Overall Study

	Armodafinil 250 mg/Day	Armodafinil 150 mg/Day	Placebo
STARTED	131	133	131
COMPLETED	110	114	120
NOT COMPLETED	21	19	11
Adverse Event	15	10	5
Protocol Violation	2	2	0
Withdrawal by Subject	1	5	3
Lost to Follow-up	0	1	1
Physician Decision	2	0	1
Miscellaneous	1	1	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

Baseline Measures

	Armodafinil 250 mg/Day	Armodafinil 150 mg/Day	Placebo	Total
Number of Participants [units: participants]	131	131	130	392
Age ^[1] [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	130	131	129	390
>=65 years	1	0	1	2
Age [units: years] Mean ± Standard Deviation	49.1 ± 8.74	49.3 ± 9.17	50.1 ± 9.43	49.5 ± 9.10
Gender ^[1] [units: participants]
Female	42	34	40	116
Male	89	97	90	276
Region of Enrollment [units: participants]
United States	117	119	117	353
Canada	14	14	14	42

[1]	3 female patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)

Outcome Measures

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1. Primary:

Maintenance of Wakefulness Test (MWT) [ Time Frame: change from baseline at 12 weeks ]

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2. Primary:

Clinical Global Impression of Change (CGI-C) [ 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
phone: 1-877-237-4879

No publications provided

ClinicalTrials.gov Identifier:	NCT00078325 History of Changes
Other Study ID Numbers:	C10953/3021/AP/MN
Study First Received:	February 23, 2004
Results First Received:	June 1, 2009
Last Updated:	July 6, 2010
Health Authority:	United States: Food and Drug Administration