Trial Outcomes & Findings for Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss (NCT NCT01096680)
NCT ID: NCT01096680
Last Updated: 2021-06-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
Over a period of 8 hours
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
SPD489 20 mg
A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 50 mg
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 70 mg
A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Armodafinil 250 mg
A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Placebo
A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
27
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
Baseline characteristics by cohort
| Measure |
SPD489 20 mg
n=27 Participants
A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 50 mg
n=27 Participants
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 70 mg
n=27 Participants
A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Armodafinil 250 mg
n=27 Participants
A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Placebo
n=27 Participants
A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 5.03 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 5.95 • n=7 Participants
|
28.3 years
STANDARD_DEVIATION 5.04 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 5.09 • n=4 Participants
|
28.1 years
STANDARD_DEVIATION 6.83 • n=21 Participants
|
27.7 years
STANDARD_DEVIATION 5.62 • n=10 Participants
|
|
Age, Customized
18 to 40 years
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
135 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
135 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
135 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Over a period of 8 hoursPopulation: Full Analysis Set (FAS) is defined as all randomized subjects with any primary efficacy assessment.
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.
Outcome measures
| Measure |
SPD489 20 mg
n=27 Participants
A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 50 mg
n=27 Participants
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 70 mg
n=27 Participants
A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Armodafinil 250 mg
n=27 Participants
A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Placebo
n=27 Participants
A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
|---|---|---|---|---|---|
|
Maintenance of Wakefulness Test (MWT)
|
23.3 Minutes
Standard Error 1.10
|
27.9 Minutes
Standard Error 0.64
|
29.3 Minutes
Standard Error 0.44
|
27.6 Minutes
Standard Error 0.63
|
15.3 Minutes
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Over a period of 15 hoursPopulation: FAS
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.
Outcome measures
| Measure |
SPD489 20 mg
n=27 Participants
A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 50 mg
n=27 Participants
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 70 mg
n=27 Participants
A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Armodafinil 250 mg
n=27 Participants
A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Placebo
n=27 Participants
A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
|---|---|---|---|---|---|
|
Karolinska Sleepiness Scale (KSS) Scores
|
4.7 Units on a scale
Standard Error 0.21
|
4.0 Units on a scale
Standard Error 0.21
|
3.6 Units on a scale
Standard Error 0.21
|
4.7 Units on a scale
Standard Error 0.21
|
5.2 Units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Over a period of 15 hoursPopulation: FAS
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.
Outcome measures
| Measure |
SPD489 20 mg
n=27 Participants
A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 50 mg
n=27 Participants
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 70 mg
n=27 Participants
A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Armodafinil 250 mg
n=27 Participants
A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Placebo
n=27 Participants
A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
|---|---|---|---|---|---|
|
KSS Scores by Timepoint
7:50pm
|
2.9 Units on a scale
Standard Error 0.19
|
3.0 Units on a scale
Standard Error 0.19
|
2.6 Units on a scale
Standard Error 0.19
|
2.6 Units on a scale
Standard Error 0.19
|
2.8 Units on a scale
Standard Error 0.19
|
|
KSS Scores by Timepoint
8:50pm
|
2.7 Units on a scale
Standard Error 0.20
|
2.7 Units on a scale
Standard Error 0.20
|
2.6 Units on a scale
Standard Error 0.20
|
2.7 Units on a scale
Standard Error 0.20
|
3.0 Units on a scale
Standard Error 0.20
|
|
KSS Scores by Timepoint
9:50pm
|
2.9 Units on a scale
Standard Error 0.23
|
3.1 Units on a scale
Standard Error 0.23
|
2.6 Units on a scale
Standard Error 0.23
|
3.1 Units on a scale
Standard Error 0.23
|
3.1 Units on a scale
Standard Error 0.23
|
|
KSS Scores by Timepoint
10:50pm
|
2.8 Units on a scale
Standard Error 0.26
|
3.2 Units on a scale
Standard Error 0.26
|
2.4 Units on a scale
Standard Error 0.27
|
2.9 Units on a scale
Standard Error 0.26
|
3.7 Units on a scale
Standard Error 0.27
|
|
KSS Scores by Timepoint
11:50pm
|
3.2 Units on a scale
Standard Error 0.29
|
3.1 Units on a scale
Standard Error 0.29
|
2.5 Units on a scale
Standard Error 0.29
|
3.4 Units on a scale
Standard Error 0.29
|
3.9 Units on a scale
Standard Error 0.29
|
|
KSS Scores by Timepoint
12:50am
|
3.6 Units on a scale
Standard Error 0.29
|
2.9 Units on a scale
Standard Error 0.29
|
2.6 Units on a scale
Standard Error 0.29
|
3.3 Units on a scale
Standard Error 0.29
|
4.5 Units on a scale
Standard Error 0.29
|
|
KSS Scores by Timepoint
1:50am
|
4.0 Units on a scale
Standard Error 0.31
|
3.2 Units on a scale
Standard Error 0.31
|
3.0 Units on a scale
Standard Error 0.31
|
3.8 Units on a scale
Standard Error 0.31
|
4.7 Units on a scale
Standard Error 0.31
|
|
KSS Scores by Timepoint
2:50am
|
4.5 Units on a scale
Standard Error 0.35
|
3.7 Units on a scale
Standard Error 0.35
|
3.5 Units on a scale
Standard Error 0.35
|
4.7 Units on a scale
Standard Error 0.35
|
5.7 Units on a scale
Standard Error 0.35
|
|
KSS Scores by Timepoint
3:50am
|
5.2 Units on a scale
Standard Error 0.36
|
3.9 Units on a scale
Standard Error 0.36
|
3.7 Units on a scale
Standard Error 0.36
|
5.5 Units on a scale
Standard Error 0.36
|
6.4 Units on a scale
Standard Error 0.36
|
|
KSS Scores by Timepoint
4:50am
|
6.1 Units on a scale
Standard Error 0.36
|
4.4 Units on a scale
Standard Error 0.36
|
4.2 Units on a scale
Standard Error 0.36
|
6.0 Units on a scale
Standard Error 0.36
|
6.6 Units on a scale
Standard Error 0.36
|
|
KSS Scores by Timepoint
5:50am
|
6.7 Units on a scale
Standard Error 0.37
|
5.1 Units on a scale
Standard Error 0.37
|
4.6 Units on a scale
Standard Error 0.37
|
6.3 Units on a scale
Standard Error 0.37
|
7.1 Units on a scale
Standard Error 0.37
|
|
KSS Scores by Timepoint
6:50am
|
6.7 Units on a scale
Standard Error 0.38
|
5.7 Units on a scale
Standard Error 0.38
|
4.8 Units on a scale
Standard Error 0.38
|
6.7 Units on a scale
Standard Error 0.38
|
7.3 Units on a scale
Standard Error 0.38
|
|
KSS Scores by Timepoint
7:50am
|
6.5 Units on a scale
Standard Error 0.39
|
5.5 Units on a scale
Standard Error 0.39
|
4.7 Units on a scale
Standard Error 0.39
|
6.6 Units on a scale
Standard Error 0.39
|
7.2 Units on a scale
Standard Error 0.39
|
|
KSS Scores by Timepoint
8:50am
|
5.9 Units on a scale
Standard Error 0.41
|
5.0 Units on a scale
Standard Error 0.41
|
4.4 Units on a scale
Standard Error 0.41
|
6.0 Units on a scale
Standard Error 0.41
|
5.4 Units on a scale
Standard Error 0.41
|
|
KSS Scores by Timepoint
9:50am
|
5.6 Units on a scale
Standard Error 0.38
|
4.6 Units on a scale
Standard Error 0.38
|
4.5 Units on a scale
Standard Error 0.38
|
5.7 Units on a scale
Standard Error 0.38
|
5.9 Units on a scale
Standard Error 0.38
|
|
KSS Scores by Timepoint
10:50am
|
6.2 Units on a scale
Standard Error 0.41
|
5.4 Units on a scale
Standard Error 0.41
|
5.0 Units on a scale
Standard Error 0.41
|
6.0 Units on a scale
Standard Error 0.41
|
6.2 Units on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Over a period of 12 hoursPopulation: FAS
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.
Outcome measures
| Measure |
SPD489 20 mg
n=27 Participants
A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 50 mg
n=27 Participants
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 70 mg
n=27 Participants
A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Armodafinil 250 mg
n=27 Participants
A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Placebo
n=27 Participants
A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
|---|---|---|---|---|---|
|
Psychomotor Vigilance Task (PVT) Scores
|
243.6 msec
Standard Error 3.59
|
234.8 msec
Standard Error 3.58
|
243.5 msec
Standard Error 3.58
|
243.7 msec
Standard Error 3.59
|
270.2 msec
Standard Error 3.59
|
SECONDARY outcome
Timeframe: Over a period of 12 hoursPopulation: FAS
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.
Outcome measures
| Measure |
SPD489 20 mg
n=27 Participants
A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 50 mg
n=27 Participants
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 70 mg
n=27 Participants
A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Armodafinil 250 mg
n=27 Participants
A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Placebo
n=27 Participants
A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
|---|---|---|---|---|---|
|
PVT Scores by Timepoint
9:15pm
|
231.6 msec
Standard Error 3.50
|
233.2 msec
Standard Error 3.49
|
234.9 msec
Standard Error 3.49
|
235.5 msec
Standard Error 3.49
|
241.3 msec
Standard Error 3.50
|
|
PVT Scores by Timepoint
11:15pm
|
232.6 msec
Standard Error 2.98
|
230.9 msec
Standard Error 2.97
|
231.2 msec
Standard Error 2.97
|
229.3 msec
Standard Error 2.97
|
249.3 msec
Standard Error 2.98
|
|
PVT Scores by Timepoint
1:15am
|
231.5 msec
Standard Error 3.89
|
231.5 msec
Standard Error 3.88
|
230.2 msec
Standard Error 3.89
|
233.0 msec
Standard Error 3.88
|
256.7 msec
Standard Error 3.89
|
|
PVT Scores by Timepoint
3:15am
|
243.6 msec
Standard Error 4.65
|
227.4 msec
Standard Error 4.64
|
240.7 msec
Standard Error 4.64
|
242.5 msec
Standard Error 4.64
|
280.7 msec
Standard Error 4.65
|
|
PVT Scores by Timepoint
5:15am
|
253.4 msec
Standard Error 4.67
|
237.7 msec
Standard Error 4.66
|
242.5 msec
Standard Error 4.66
|
249.5 msec
Standard Error 4.66
|
291.6 msec
Standard Error 4.67
|
|
PVT Scores by Timepoint
7:15am
|
257.9 msec
Standard Error 7.67
|
242.6 msec
Standard Error 7.67
|
259.2 msec
Standard Error 7.67
|
259.1 msec
Standard Error 7.67
|
295.5 msec
Standard Error 7.67
|
|
PVT Scores by Timepoint
9:15am
|
254.8 msec
Standard Error 10.84
|
240.0 msec
Standard Error 10.84
|
265.9 msec
Standard Error 10.84
|
256.7 msec
Standard Error 10.93
|
276.1 msec
Standard Error 10.84
|
Adverse Events
SPD489 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SPD489 50 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SPD489 70 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Armodafinil 250 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SPD489 20 mg
n=27 participants at risk
A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 50 mg
n=27 participants at risk
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
SPD489 70 mg
n=27 participants at risk
A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Armodafinil 250 mg
n=27 participants at risk
A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
Placebo
n=27 participants at risk
A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/27
Safety Analysis Set
|
14.8%
4/27
Safety Analysis Set
|
7.4%
2/27
Safety Analysis Set
|
7.4%
2/27
Safety Analysis Set
|
3.7%
1/27
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27
Safety Analysis Set
|
3.7%
1/27
Safety Analysis Set
|
7.4%
2/27
Safety Analysis Set
|
3.7%
1/27
Safety Analysis Set
|
0.00%
0/27
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27
Safety Analysis Set
|
7.4%
2/27
Safety Analysis Set
|
0.00%
0/27
Safety Analysis Set
|
0.00%
0/27
Safety Analysis Set
|
0.00%
0/27
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER