Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL

This study has been completed.

Study NCT00236080 Information provided by Cephalon

First Received on October 7, 2005. Last Updated on March 26, 2010 History of Changes

Results First Received: June 1, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Chronic Shift Work Sleep Disorder
Interventions:	Drug: PROVIGIL 200 mg Drug: Armodafinil 250 mg Drug: Armodafinil 200 mg Drug: Armodafinil 150 mg 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
16 centers in the US. First participant enrolled: 7 September 2005/ Last participant last visit: 1 December 2005

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)

Reporting Groups

	Description
PROVIGIL 200 mg/Day	PROVIGIL 200 mg once daily only on nights worked
Armodafinil 250 mg/Day	Armodafinil 250 mg once daily only on nights worked
Armodafinil 200 mg/Day	Armodafinil 200 mg once daily only on nights worked
Armodafinil 150 mg/Day	Armodafinil 150 mg once daily only on nights worked
Placebo	Matching placebo tablets once daily only on nights worked

Participant Flow: Overall Study

	PROVIGIL 200 mg/Day	Armodafinil 250 mg/Day	Armodafinil 200 mg/Day	Armodafinil 150 mg/Day	Placebo
STARTED	29	28	27	25	27
COMPLETED	27	27	22	23	26
NOT COMPLETED	2	1	5	2	1
Adverse Event	0	0	3	1	0
Lost to Follow-up	0	1	0	0	0
Physician Decision	1	0	1	1	1
Withdrawal by Subject	1	0	0	0	0
Miscellaneous	0	0	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
PROVIGIL 200 mg/Day	PROVIGIL 200 mg once daily only on nights worked
Armodafinil 250 mg/Day	Armodafinil 250 mg once daily only on nights worked
Armodafinil 200 mg/Day	Armodafinil 200 mg once daily only on nights worked
Armodafinil 150 mg/Day	Armodafinil 150 mg once daily only on nights worked
Placebo	Matching placebo tablets once daily only on nights worked

Baseline Measures

	PROVIGIL 200 mg/Day	Armodafinil 250 mg/Day	Armodafinil 200 mg/Day	Armodafinil 150 mg/Day	Placebo	Total
Number of Participants [units: participants]	29	28	27	25	27	136
Age ^[1] [units: participants]
<=18 years	0	0	0	0	0	0
Between 18 and 65 years	29	28	26	25	26	134
>=65 years	0	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	36.8 ± 8.92	34.3 ± 9.87	34.5 ± 7.60	38.3 ± 12.83	38.0 ± 9.83	36.3 ± 9.90
Gender ^[1] [units: participants]
Female	18	12	13	8	6	57
Male	11	16	13	17	20	77
Region of Enrollment ^[1] [units: participants]
United States	29	28	26	25	26	134

[1]	2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)

Outcome Measures

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1. Primary:

Multiple Sleep Latency Test (MSLT) [ Time Frame: Endpoint (Visit 4) change from baseline (Visit 2) ]

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2. Primary:

Psychomotor Vigilance Task (PVT) [ Time Frame: Endpoint (Visit 4) change from baseline (Visit 2) ]

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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
In analyzing the PVT data, it was discovered that data transfer errors had occurred at certain study centers. The ability to interpret the efficacy results from this study is limited, and the findings should be considered inconclusive.

Results Point of Contact:

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

No publications provided

Responsible Party:	Sponsor's Medical Expert, Cephalon
ClinicalTrials.gov Identifier:	NCT00236080 History of Changes
Other Study ID Numbers:	C10953/3045/CM/US
Study First Received:	October 7, 2005
Results First Received:	June 1, 2009
Last Updated:	March 26, 2010
Health Authority:	United States: Food and Drug Administration