This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
135
Single oral dose of 20 mg
Single oral dose of 50 mg
Single oral dose of 70 mg
Clinilabs, Inc.
New York, New York, United States
Maintenance of Wakefulness Test (MWT)
The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better.
Time frame: Over a period of 8 hours
Karolinska Sleepiness Scale (KSS) Scores
The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.
Time frame: Over a period of 15 hours
KSS Scores by Timepoint
The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.
Time frame: Over a period of 15 hours
Psychomotor Vigilance Task (PVT) Scores
PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.
Time frame: Over a period of 12 hours
PVT Scores by Timepoint
PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.
Time frame: Over a period of 12 hours
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Single oral dose of 250 mg
Single oral dose