Trial Outcomes & Findings for Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL (NCT NCT00236080)

Results Overview

The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

136 participants

Primary outcome timeframe

Endpoint (Visit 4) change from baseline (Visit 2)

Results posted on

2013-07-19

Participant Flow

16 centers in the US. First participant enrolled: 7 September 2005/ Last participant last visit: 1 December 2005

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

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	29	28	27	25	27
Overall Study COMPLETED	27	27	22	23	26
Overall Study NOT COMPLETED	2	1	5	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	0	0	3	1	0
Overall Study Lost to Follow-up	0	1	0	0	0
Overall Study Physician Decision	1	0	1	1	1
Overall Study Withdrawal by Subject	1	0	0	0	0
Overall Study Miscellaneous	0	0	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PROVIGIL 200 mg/Day n=29 Participants PROVIGIL 200 mg once daily only on nights worked	Armodafinil 250 mg/Day n=28 Participants Armodafinil 250 mg once daily only on nights worked	Armodafinil 200 mg/Day n=27 Participants Armodafinil 200 mg once daily only on nights worked	Armodafinil 150 mg/Day n=25 Participants Armodafinil 150 mg once daily only on nights worked	Placebo n=27 Participants Matching placebo tablets once daily only on nights worked	Total n=136 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	0 participants n=36 Participants	0 participants n=10 Participants
Age Categorical Between 18 and 65 years	29 participants n=93 Participants	28 participants n=4 Participants	26 participants n=27 Participants	25 participants n=483 Participants	26 participants n=36 Participants	134 participants n=10 Participants
Age Categorical >=65 years	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	0 participants n=36 Participants	0 participants n=10 Participants
Age Continuous	36.8 years STANDARD_DEVIATION 8.92 • n=93 Participants	34.3 years STANDARD_DEVIATION 9.87 • n=4 Participants	34.5 years STANDARD_DEVIATION 7.60 • n=27 Participants	38.3 years STANDARD_DEVIATION 12.83 • n=483 Participants	38.0 years STANDARD_DEVIATION 9.83 • n=36 Participants	36.3 years STANDARD_DEVIATION 9.90 • n=10 Participants
Gender Female	18 participants n=93 Participants	12 participants n=4 Participants	13 participants n=27 Participants	8 participants n=483 Participants	6 participants n=36 Participants	57 participants n=10 Participants
Gender Male	11 participants n=93 Participants	16 participants n=4 Participants	13 participants n=27 Participants	17 participants n=483 Participants	20 participants n=36 Participants	77 participants n=10 Participants
Region of Enrollment United States	29 participants n=93 Participants	28 participants n=4 Participants	26 participants n=27 Participants	25 participants n=483 Participants	26 participants n=36 Participants	134 participants n=10 Participants

PRIMARY outcome

Timeframe: Endpoint (Visit 4) change from baseline (Visit 2)

Population: * 1 Placebo Patient did not have an MSLT but did complete the other Primary Measure (PVT) and other requirements. This patient was termed a "Completer". * 1 Patient in the "Armodafinil 200 mg/day group" had an MSLT performed but then discontinued the study drug before reaching the study endpoint and was termed a "Non-Completer" for the Study.

The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.

Outcome measures

Outcome measures
Measure	PROVIGIL 200 mg/Day n=27 Participants PROVIGIL 200 mg once daily only on nights worked	Armodafinil 250 mg/Day n=27 Participants Armodafinil 250 mg once daily only on nights worked	Armodafinil 200 mg/Day n=23 Participants Armodafinil 200 mg once daily only on nights worked	Armodafinil 150 mg/Day n=23 Participants Armodafinil 150 mg once daily only on nights worked	Placebo n=25 Participants Matching placebo tablets once daily only on nights worked
Multiple Sleep Latency Test (MSLT)	2.0 Minutes Standard Deviation 3.05	3.7 Minutes Standard Deviation 4.33	3.7 Minutes Standard Deviation 5.07	2.7 Minutes Standard Deviation 4.24	1.1 Minutes Standard Deviation 3.76

PRIMARY outcome

Timeframe: Endpoint (Visit 4) change from baseline (Visit 2)

Population: Of the patients who completed the study, 1 patient in the PROVIGIL 200 mg/day treatment group and 1 patient in the Armodafinil 150 mg/day treatment group did not complete their PVT assessment.

The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.