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

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[2] [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.  Primary:

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

2.  Primary:

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