Sleep Deprivation
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Single oral dose
DRUGSPD489 20 mg
Single oral dose of 20 mg
DRUGSPD489 50 mg
Single oral dose of 50 mg
DRUGSPD489 70 mg
Single oral dose of 70 mg
DRUGArmodafinil
Single oral dose of 250 mg
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Male subjects between the ages of 18-40 years. * The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis). * Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends. * Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.
Exclusion criteria
* Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus. * Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation. * Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) \>10.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Wakefulness Test (MWT) | Over a period of 8 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Karolinska Sleepiness Scale (KSS) Scores | Over a period of 15 hours | 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. |
| KSS Scores by Timepoint | Over a period of 15 hours | 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. |
| Psychomotor Vigilance Task (PVT) Scores | Over a period of 12 hours | 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. |
| PVT Scores by Timepoint | Over a period of 12 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SPD489 20 mg A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 27 |
| SPD489 50 mg A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 27 |
| SPD489 70 mg A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 27 |
| Armodafinil 250 mg A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 27 |
| Placebo A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 27 |
| Total | 135 |
Baseline characteristics
| Characteristic | SPD489 20 mg | SPD489 50 mg | SPD489 70 mg | Armodafinil 250 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 26.4 years STANDARD_DEVIATION 5.03 | 28.7 years STANDARD_DEVIATION 5.95 | 28.3 years STANDARD_DEVIATION 5.04 | 27.0 years STANDARD_DEVIATION 5.09 | 28.1 years STANDARD_DEVIATION 6.83 | 27.7 years STANDARD_DEVIATION 5.62 |
| Age, Customized 18 to 40 years | 27 Participants | 27 Participants | 27 Participants | 27 Participants | 27 Participants | 135 Participants |
| Region of Enrollment United States | 27 Participants | 27 Participants | 27 Participants | 27 Participants | 27 Participants | 135 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 27 Participants | 27 Participants | 27 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 27 | 5 / 27 | 4 / 27 | 3 / 27 | 1 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 0 / 27 | 0 / 27 | 0 / 27 |
Outcome results
Primary
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
Population: Full Analysis Set (FAS) is defined as all randomized subjects with any primary efficacy assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SPD489 20 mg | Maintenance of Wakefulness Test (MWT) | 23.3 Minutes | Standard Error 1.1 |
| SPD489 50 mg | Maintenance of Wakefulness Test (MWT) | 27.9 Minutes | Standard Error 0.64 |
| SPD489 70 mg | Maintenance of Wakefulness Test (MWT) | 29.3 Minutes | Standard Error 0.44 |
| Armodafinil 250 mg | Maintenance of Wakefulness Test (MWT) | 27.6 Minutes | Standard Error 0.63 |
| Placebo | Maintenance of Wakefulness Test (MWT) | 15.3 Minutes | Standard Error 1 |
p-value: <0.000195% CI: [5, 10.9]Mixed Models Analysis
p-value: <0.000195% CI: [10.2, 15]Mixed Models Analysis
p-value: <0.000195% CI: [11.7, 16.2]Mixed Models Analysis
p-value: <0.000195% CI: [9.9, 14.7]Mixed Models Analysis
p-value: 0.001495% CI: [-6.9, -1.8]Mixed Models Analysis
p-value: 0.760195% CI: [-1.5, 2.1]Mixed Models Analysis
p-value: 0.035195% CI: [0.1, 3.2]Mixed Models Analysis
Secondary
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
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SPD489 20 mg | Karolinska Sleepiness Scale (KSS) Scores | 4.7 Units on a scale | Standard Error 0.21 |
| SPD489 50 mg | Karolinska Sleepiness Scale (KSS) Scores | 4.0 Units on a scale | Standard Error 0.21 |
| SPD489 70 mg | Karolinska Sleepiness Scale (KSS) Scores | 3.6 Units on a scale | Standard Error 0.21 |
| Armodafinil 250 mg | Karolinska Sleepiness Scale (KSS) Scores | 4.7 Units on a scale | Standard Error 0.21 |
| Placebo | Karolinska Sleepiness Scale (KSS) Scores | 5.2 Units on a scale | Standard Error 0.21 |
p-value: 0.112395% CI: [-1.1, 0.1]Mixed Models Analysis
p-value: 0.000295% CI: [-1.8, -0.6]Mixed Models Analysis
p-value: <0.000195% CI: [-2.2, -1]Mixed Models Analysis
p-value: 0.094795% CI: [-1.1, 0.1]Mixed Models Analysis
p-value: 0.939395% CI: [-0.6, 0.6]Mixed Models Analysis
p-value: 0.029795% CI: [-1.3, -0.1]Mixed Models Analysis
p-value: 0.000495% CI: [-1.7, -0.5]Mixed Models Analysis
Secondary
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
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 20 mg | KSS Scores by Timepoint | 11:50pm | 3.2 Units on a scale | Standard Error 0.29 |
| SPD489 20 mg | KSS Scores by Timepoint | 8:50pm | 2.7 Units on a scale | Standard Error 0.2 |
| SPD489 20 mg | KSS Scores by Timepoint | 9:50pm | 2.9 Units on a scale | Standard Error 0.23 |
| SPD489 20 mg | KSS Scores by Timepoint | 10:50pm | 2.8 Units on a scale | Standard Error 0.26 |
| SPD489 20 mg | KSS Scores by Timepoint | 7:50pm | 2.9 Units on a scale | Standard Error 0.19 |
| SPD489 20 mg | KSS Scores by Timepoint | 12:50am | 3.6 Units on a scale | Standard Error 0.29 |
| SPD489 20 mg | KSS Scores by Timepoint | 1:50am | 4.0 Units on a scale | Standard Error 0.31 |
| SPD489 20 mg | KSS Scores by Timepoint | 2:50am | 4.5 Units on a scale | Standard Error 0.35 |
| SPD489 20 mg | KSS Scores by Timepoint | 3:50am | 5.2 Units on a scale | Standard Error 0.36 |
| SPD489 20 mg | KSS Scores by Timepoint | 4:50am | 6.1 Units on a scale | Standard Error 0.36 |
| SPD489 20 mg | KSS Scores by Timepoint | 5:50am | 6.7 Units on a scale | Standard Error 0.37 |
| SPD489 20 mg | KSS Scores by Timepoint | 6:50am | 6.7 Units on a scale | Standard Error 0.38 |
| SPD489 20 mg | KSS Scores by Timepoint | 7:50am | 6.5 Units on a scale | Standard Error 0.39 |
| SPD489 20 mg | KSS Scores by Timepoint | 8:50am | 5.9 Units on a scale | Standard Error 0.41 |
| SPD489 20 mg | KSS Scores by Timepoint | 9:50am | 5.6 Units on a scale | Standard Error 0.38 |
| SPD489 20 mg | KSS Scores by Timepoint | 10:50am | 6.2 Units on a scale | Standard Error 0.41 |
| SPD489 50 mg | KSS Scores by Timepoint | 8:50am | 5.0 Units on a scale | Standard Error 0.41 |
| SPD489 50 mg | KSS Scores by Timepoint | 4:50am | 4.4 Units on a scale | Standard Error 0.36 |
| SPD489 50 mg | KSS Scores by Timepoint | 3:50am | 3.9 Units on a scale | Standard Error 0.36 |
| SPD489 50 mg | KSS Scores by Timepoint | 9:50am | 4.6 Units on a scale | Standard Error 0.38 |
| SPD489 50 mg | KSS Scores by Timepoint | 2:50am | 3.7 Units on a scale | Standard Error 0.35 |
| SPD489 50 mg | KSS Scores by Timepoint | 11:50pm | 3.1 Units on a scale | Standard Error 0.29 |
| SPD489 50 mg | KSS Scores by Timepoint | 10:50pm | 3.2 Units on a scale | Standard Error 0.26 |
| SPD489 50 mg | KSS Scores by Timepoint | 8:50pm | 2.7 Units on a scale | Standard Error 0.2 |
| SPD489 50 mg | KSS Scores by Timepoint | 7:50pm | 3.0 Units on a scale | Standard Error 0.19 |
| SPD489 50 mg | KSS Scores by Timepoint | 7:50am | 5.5 Units on a scale | Standard Error 0.39 |
| SPD489 50 mg | KSS Scores by Timepoint | 12:50am | 2.9 Units on a scale | Standard Error 0.29 |
| SPD489 50 mg | KSS Scores by Timepoint | 9:50pm | 3.1 Units on a scale | Standard Error 0.23 |
| SPD489 50 mg | KSS Scores by Timepoint | 10:50am | 5.4 Units on a scale | Standard Error 0.41 |
| SPD489 50 mg | KSS Scores by Timepoint | 6:50am | 5.7 Units on a scale | Standard Error 0.38 |
| SPD489 50 mg | KSS Scores by Timepoint | 5:50am | 5.1 Units on a scale | Standard Error 0.37 |
| SPD489 50 mg | KSS Scores by Timepoint | 1:50am | 3.2 Units on a scale | Standard Error 0.31 |
| SPD489 70 mg | KSS Scores by Timepoint | 8:50am | 4.4 Units on a scale | Standard Error 0.41 |
| SPD489 70 mg | KSS Scores by Timepoint | 10:50pm | 2.4 Units on a scale | Standard Error 0.27 |
| SPD489 70 mg | KSS Scores by Timepoint | 11:50pm | 2.5 Units on a scale | Standard Error 0.29 |
| SPD489 70 mg | KSS Scores by Timepoint | 12:50am | 2.6 Units on a scale | Standard Error 0.29 |
| SPD489 70 mg | KSS Scores by Timepoint | 1:50am | 3.0 Units on a scale | Standard Error 0.31 |
| SPD489 70 mg | KSS Scores by Timepoint | 2:50am | 3.5 Units on a scale | Standard Error 0.35 |
| SPD489 70 mg | KSS Scores by Timepoint | 9:50am | 4.5 Units on a scale | Standard Error 0.38 |
| SPD489 70 mg | KSS Scores by Timepoint | 3:50am | 3.7 Units on a scale | Standard Error 0.36 |
| SPD489 70 mg | KSS Scores by Timepoint | 4:50am | 4.2 Units on a scale | Standard Error 0.36 |
| SPD489 70 mg | KSS Scores by Timepoint | 5:50am | 4.6 Units on a scale | Standard Error 0.37 |
| SPD489 70 mg | KSS Scores by Timepoint | 6:50am | 4.8 Units on a scale | Standard Error 0.38 |
| SPD489 70 mg | KSS Scores by Timepoint | 7:50am | 4.7 Units on a scale | Standard Error 0.39 |
| SPD489 70 mg | KSS Scores by Timepoint | 7:50pm | 2.6 Units on a scale | Standard Error 0.19 |
| SPD489 70 mg | KSS Scores by Timepoint | 10:50am | 5.0 Units on a scale | Standard Error 0.41 |
| SPD489 70 mg | KSS Scores by Timepoint | 8:50pm | 2.6 Units on a scale | Standard Error 0.2 |
| SPD489 70 mg | KSS Scores by Timepoint | 9:50pm | 2.6 Units on a scale | Standard Error 0.23 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 4:50am | 6.0 Units on a scale | Standard Error 0.36 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 10:50am | 6.0 Units on a scale | Standard Error 0.41 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 5:50am | 6.3 Units on a scale | Standard Error 0.37 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 8:50am | 6.0 Units on a scale | Standard Error 0.41 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 6:50am | 6.7 Units on a scale | Standard Error 0.38 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 12:50am | 3.3 Units on a scale | Standard Error 0.29 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 7:50am | 6.6 Units on a scale | Standard Error 0.39 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 10:50pm | 2.9 Units on a scale | Standard Error 0.26 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 7:50pm | 2.6 Units on a scale | Standard Error 0.19 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 9:50pm | 3.1 Units on a scale | Standard Error 0.23 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 2:50am | 4.7 Units on a scale | Standard Error 0.35 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 11:50pm | 3.4 Units on a scale | Standard Error 0.29 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 3:50am | 5.5 Units on a scale | Standard Error 0.36 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 9:50am | 5.7 Units on a scale | Standard Error 0.38 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 1:50am | 3.8 Units on a scale | Standard Error 0.31 |
| Armodafinil 250 mg | KSS Scores by Timepoint | 8:50pm | 2.7 Units on a scale | Standard Error 0.2 |
| Placebo | KSS Scores by Timepoint | 7:50am | 7.2 Units on a scale | Standard Error 0.39 |
| Placebo | KSS Scores by Timepoint | 4:50am | 6.6 Units on a scale | Standard Error 0.36 |
| Placebo | KSS Scores by Timepoint | 9:50am | 5.9 Units on a scale | Standard Error 0.38 |
| Placebo | KSS Scores by Timepoint | 11:50pm | 3.9 Units on a scale | Standard Error 0.29 |
| Placebo | KSS Scores by Timepoint | 8:50pm | 3.0 Units on a scale | Standard Error 0.2 |
| Placebo | KSS Scores by Timepoint | 2:50am | 5.7 Units on a scale | Standard Error 0.35 |
| Placebo | KSS Scores by Timepoint | 5:50am | 7.1 Units on a scale | Standard Error 0.37 |
| Placebo | KSS Scores by Timepoint | 10:50am | 6.2 Units on a scale | Standard Error 0.41 |
| Placebo | KSS Scores by Timepoint | 12:50am | 4.5 Units on a scale | Standard Error 0.29 |
| Placebo | KSS Scores by Timepoint | 3:50am | 6.4 Units on a scale | Standard Error 0.36 |
| Placebo | KSS Scores by Timepoint | 7:50pm | 2.8 Units on a scale | Standard Error 0.19 |
| Placebo | KSS Scores by Timepoint | 6:50am | 7.3 Units on a scale | Standard Error 0.38 |
| Placebo | KSS Scores by Timepoint | 1:50am | 4.7 Units on a scale | Standard Error 0.31 |
| Placebo | KSS Scores by Timepoint | 8:50am | 5.4 Units on a scale | Standard Error 0.41 |
| Placebo | KSS Scores by Timepoint | 10:50pm | 3.7 Units on a scale | Standard Error 0.27 |
| Placebo | KSS Scores by Timepoint | 9:50pm | 3.1 Units on a scale | Standard Error 0.23 |
Comparison: 7:50pmp-value: 0.983195% CI: [-0.5, 0.5]Mixed Models Analysis
Comparison: 7:50pmp-value: 0.775895% CI: [-0.5, 0.6]Mixed Models Analysis
Comparison: 7:50pmp-value: 0.179895% CI: [-0.2, 0.9]Mixed Models Analysis
Comparison: 7:50pmp-value: 0.60995% CI: [-0.4, 0.7]Mixed Models Analysis
Comparison: 7:50pmp-value: 0.116995% CI: [-0.1, 1]Mixed Models Analysis
Comparison: 7:50pmp-value: 0.302895% CI: [-0.8, 0.3]Mixed Models Analysis
Comparison: 7:50pmp-value: 0.288795% CI: [-0.8, 0.2]Mixed Models Analysis
Comparison: 8:50pmp-value: 0.439595% CI: [-0.8, 0.3]Mixed Models Analysis
Comparison: 8:50pmp-value: 0.901995% CI: [-0.5, 0.6]Mixed Models Analysis
Comparison: 8:50pmp-value: 0.341995% CI: [-0.8, 0.3]Mixed Models Analysis
Comparison: 8:50pmp-value: 0.958195% CI: [-0.6, 0.5]Mixed Models Analysis
Comparison: 8:50pmp-value: 0.257295% CI: [-0.9, 0.2]Mixed Models Analysis
Comparison: 8:50pmp-value: 0.808595% CI: [-0.6, 0.5]Mixed Models Analysis
Comparison: 8:50pmp-value: 0.367895% CI: [-0.8, 0.3]Mixed Models Analysis
Comparison: 9:50pmp-value: 0.373295% CI: [-0.9, 0.4]Mixed Models Analysis
Comparison: 9:50pmp-value: 0.492495% CI: [-0.9, 0.4]Mixed Models Analysis
Comparison: 9:50pmp-value: 0.979895% CI: [-0.7, 0.6]Mixed Models Analysis
Comparison: 9:50pmp-value: 0.855795% CI: [-0.6, 0.7]Mixed Models Analysis
Comparison: 9:50pmp-value: 0.099895% CI: [-1.2, 0.1]Mixed Models Analysis
Comparison: 9:50pmp-value: 0.147995% CI: [-1.1, 0.2]Mixed Models Analysis
Comparison: 9:50pmp-value: 0.835895% CI: [-0.7, 0.6]Mixed Models Analysis
Comparison: 10:50pmp-value: 0.019995% CI: [-1.6, -0.1]Mixed Models Analysis
Comparison: 10:50pmp-value: 0.762595% CI: [-0.9, 0.6]Mixed Models Analysis
Comparison: 10:50pmp-value: 0.193695% CI: [-1.2, 0.3]Mixed Models Analysis
Comparison: 10:50pmp-value: 0.453495% CI: [-0.5, 1]Mixed Models Analysis
Comparison: 10:50pmp-value: 0.001295% CI: [-2, -0.5]Mixed Models Analysis
Comparison: 10:50pmp-value: 0.207295% CI: [-1.2, 0.3]Mixed Models Analysis
Comparison: 10:50pmp-value: 0.041395% CI: [-1.5, 0]Mixed Models Analysis
Comparison: 11:50pmp-value: 0.108695% CI: [-1.5, 0.1]Mixed Models Analysis
Comparison: 11:50pmp-value: 0.584395% CI: [-1, 0.6]Mixed Models Analysis
Comparison: 11:50pmp-value: 0.057195% CI: [-1.6, 0]Mixed Models Analysis
Comparison: 11:50pmp-value: 0.396595% CI: [-1.2, 0.5]Mixed Models Analysis
Comparison: 11:50pmp-value: 0.000995% CI: [-2.2, -0.6]Mixed Models Analysis
Comparison: 11:50pmp-value: 0.021195% CI: [-1.8, -0.1]Mixed Models Analysis
Comparison: 11:50pmp-value: 0.286395% CI: [-1.2, 0.4]Mixed Models Analysis
Comparison: 12:50amp-value: 0.042895% CI: [-1.7, 0]Mixed Models Analysis
Comparison: 12:50amp-value: 0.375795% CI: [-0.5, 1.2]Mixed Models Analysis
Comparison: 12:50amp-value: 0.000295% CI: [-2.4, -0.8]Mixed Models Analysis
Comparison: 12:50amp-value: 0.353595% CI: [-1.2, 0.4]Mixed Models Analysis
Comparison: 12:50amp-value: <0.000195% CI: [-2.7, -1.1]Mixed Models Analysis
Comparison: 12:50amp-value: 0.113195% CI: [-1.5, 0.2]Mixed Models Analysis
Comparison: 12:50amp-value: 0.003995% CI: [-2, -0.4]Mixed Models Analysis
Comparison: 1:50amp-value: 0.130295% CI: [-1.5, 0.2]Mixed Models Analysis
Comparison: 1:50amp-value: 0.613895% CI: [-0.6, 1.1]Mixed Models Analysis
Comparison: 1:50amp-value: 0.000895% CI: [-2.3, -0.6]Mixed Models Analysis
Comparison: 1:50amp-value: 0.164395% CI: [-1.5, 0.3]Mixed Models Analysis
Comparison: 1:50amp-value: 0.000295% CI: [-2.5, -0.8]Mixed Models Analysis
Comparison: 1:50amp-value: 0.078295% CI: [-1.6, 0.1]Mixed Models Analysis
Comparison: 1:50amp-value: 0.044195% CI: [-1.7, 0]Mixed Models Analysis
Comparison: 2:50amp-value: 0.019395% CI: [-2.2, -0.2]Mixed Models Analysis
Comparison: 2:50amp-value: 0.707195% CI: [-1.2, 0.8]Mixed Models Analysis
Comparison: 2:50amp-value: 0.000295% CI: [-2.9, -0.9]Mixed Models Analysis
Comparison: 2:50amp-value: 0.061195% CI: [-1.9, 0]Mixed Models Analysis
Comparison: 2:50amp-value: <0.000195% CI: [-3.2, -1.2]Mixed Models Analysis
Comparison: 2:50amp-value: 0.01695% CI: [-2.2, -0.2]Mixed Models Analysis
Comparison: 2:50amp-value: 0.04895% CI: [-2, 0]Mixed Models Analysis
Comparison: 3:50amp-value: 0.023495% CI: [-2.2, -0.2]Mixed Models Analysis
Comparison: 3:50amp-value: 0.562495% CI: [-1.3, 0.7]Mixed Models Analysis
Comparison: 3:50amp-value: <0.000195% CI: [-3.5, -1.5]Mixed Models Analysis
Comparison: 3:50amp-value: 0.002295% CI: [-2.6, -0.6]Mixed Models Analysis
Comparison: 3:50amp-value: <0.000195% CI: [-3.7, -1.6]Mixed Models Analysis
Comparison: 3:50amp-value: 0.000895% CI: [-2.8, -0.8]Mixed Models Analysis
Comparison: 3:50amp-value: 0.088395% CI: [-1.9, 0.1]Mixed Models Analysis
Comparison: 4:50amp-value: 0.309395% CI: [-1.5, 0.5]Mixed Models Analysis
Comparison: 4:50amp-value: 0.887195% CI: [-0.9, 1.1]Mixed Models Analysis
Comparison: 4:50amp-value: <0.000195% CI: [-3.2, -1.2]Mixed Models Analysis
Comparison: 4:50amp-value: 0.002295% CI: [-2.6, -0.6]Mixed Models Analysis
Comparison: 4:50amp-value: <0.000195% CI: [-3.4, -1.4]Mixed Models Analysis
Comparison: 4:50amp-value: 0.000695% CI: [-2.8, -0.8]Mixed Models Analysis
Comparison: 4:50amp-value: 0.246295% CI: [-1.6, 0.4]Mixed Models Analysis
Comparison: 5:50amp-value: 0.442795% CI: [-1.4, 0.6]Mixed Models Analysis
Comparison: 5:50amp-value: 0.440595% CI: [-0.6, 1.4]Mixed Models Analysis
Comparison: 5:50amp-value: 0.000395% CI: [-3, -0.9]Mixed Models Analysis
Comparison: 5:50amp-value: 0.027995% CI: [-2.2, -0.1]Mixed Models Analysis
Comparison: 5:50amp-value: <0.000195% CI: [-3.5, -1.5]Mixed Models Analysis
Comparison: 5:50amp-value: 0.001595% CI: [-2.7, -0.7]Mixed Models Analysis
Comparison: 5:50amp-value: 0.124695% CI: [-1.8, 0.2]Mixed Models Analysis
Comparison: 6:50amp-value: 0.306795% CI: [-1.6, 0.5]Mixed Models Analysis
Comparison: 6:50amp-value: 0.89495% CI: [-1, 1.1]Mixed Models Analysis
Comparison: 6:50amp-value: 0.003495% CI: [-2.7, -0.5]Mixed Models Analysis
Comparison: 6:50amp-value: 0.070895% CI: [-2, 0.1]Mixed Models Analysis
Comparison: 6:50amp-value: <0.000195% CI: [-3.6, -1.4]Mixed Models Analysis
Comparison: 6:50amp-value: 0.000695% CI: [-2.9, -0.8]Mixed Models Analysis
Comparison: 6:50amp-value: 0.247695% CI: [-1.7, 0.4]Mixed Models Analysis
Comparison: 7:50amp-value: 0.23195% CI: [-1.8, 0.4]Mixed Models Analysis
Comparison: 7:50amp-value: 0.836995% CI: [-1.2, 1]Mixed Models Analysis
Comparison: 7:50amp-value: 0.003595% CI: [-2.7, -0.5]Mixed Models Analysis
Comparison: 7:50amp-value: 0.049895% CI: [-2.2, 0]Mixed Models Analysis
Comparison: 7:50amp-value: <0.000195% CI: [-3.6, -1.4]Mixed Models Analysis
Comparison: 7:50amp-value: 0.000795% CI: [-3, -0.8]Mixed Models Analysis
Comparison: 7:50amp-value: 0.319895% CI: [-1.6, 0.5]Mixed Models Analysis
Comparison: 8:50amp-value: 0.37595% CI: [-0.6, 1.7]Mixed Models Analysis
Comparison: 8:50amp-value: 0.797895% CI: [-1.3, 1]Mixed Models Analysis
Comparison: 8:50amp-value: 0.519795% CI: [-1.5, 0.8]Mixed Models Analysis
Comparison: 8:50amp-value: 0.075195% CI: [-2.2, 0.1]Mixed Models Analysis
Comparison: 8:50amp-value: 0.107995% CI: [-2.1, 0.2]Mixed Models Analysis
Comparison: 8:50amp-value: 0.006595% CI: [-2.8, -0.5]Mixed Models Analysis
Comparison: 8:50amp-value: 0.252995% CI: [-0.5, 1.8]Mixed Models Analysis
Comparison: 9:50amp-value: 0.636495% CI: [-1.3, 0.8]Mixed Models Analysis
Comparison: 9:50amp-value: 0.941795% CI: [-1.1, 1]Mixed Models Analysis
Comparison: 9:50amp-value: 0.0295% CI: [-2.3, -0.2]Mixed Models Analysis
Comparison: 9:50amp-value: 0.052795% CI: [-2.1, 0]Mixed Models Analysis
Comparison: 9:50amp-value: 0.010795% CI: [-2.5, -0.3]Mixed Models Analysis
Comparison: 9:50amp-value: 0.030395% CI: [-2.2, -0.1]Mixed Models Analysis
Comparison: 9:50amp-value: 0.688995% CI: [-1.3, 0.8]Mixed Models Analysis
Comparison: 10:50amp-value: 0.955295% CI: [-1.2, 1.1]Mixed Models Analysis
Comparison: 10:50amp-value: 0.755895% CI: [-1, 1.3]Mixed Models Analysis
Comparison: 10:50amp-value: 0.182495% CI: [-1.9, 0.4]Mixed Models Analysis
Comparison: 10:50amp-value: 0.332395% CI: [-1.7, 0.6]Mixed Models Analysis
Comparison: 10:50amp-value: 0.041395% CI: [-2.4, 0]Mixed Models Analysis
Comparison: 10:50amp-value: 0.092595% CI: [-2.2, 0.2]Mixed Models Analysis
Comparison: 10:50amp-value: 0.713395% CI: [-1.4, 0.9]Mixed Models Analysis
Secondary
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
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SPD489 20 mg | Psychomotor Vigilance Task (PVT) Scores | 243.6 msec | Standard Error 3.59 |
| SPD489 50 mg | Psychomotor Vigilance Task (PVT) Scores | 234.8 msec | Standard Error 3.58 |
| SPD489 70 mg | Psychomotor Vigilance Task (PVT) Scores | 243.5 msec | Standard Error 3.58 |
| Armodafinil 250 mg | Psychomotor Vigilance Task (PVT) Scores | 243.7 msec | Standard Error 3.59 |
| Placebo | Psychomotor Vigilance Task (PVT) Scores | 270.2 msec | Standard Error 3.59 |
p-value: <0.000195% CI: [-36.6, -16.5]Mixed Models Analysis
p-value: <0.000195% CI: [-45.5, -25.4]Mixed Models Analysis
p-value: <0.000195% CI: [-36.7, -16.6]Mixed Models Analysis
p-value: <0.000195% CI: [-36.6, -16.5]Mixed Models Analysis
p-value: 0.994595% CI: [-10.1, 10]Mixed Models Analysis
p-value: 0.081495% CI: [-18.9, 1.1]Mixed Models Analysis
p-value: 0.974395% CI: [-10.2, 9.9]Mixed Models Analysis
Secondary
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
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 20 mg | PVT Scores by Timepoint | 9:15pm | 231.6 msec | Standard Error 3.5 |
| SPD489 20 mg | PVT Scores by Timepoint | 9:15am | 254.8 msec | Standard Error 10.84 |
| SPD489 20 mg | PVT Scores by Timepoint | 7:15am | 257.9 msec | Standard Error 7.67 |
| SPD489 20 mg | PVT Scores by Timepoint | 1:15am | 231.5 msec | Standard Error 3.89 |
| SPD489 20 mg | PVT Scores by Timepoint | 11:15pm | 232.6 msec | Standard Error 2.98 |
| SPD489 20 mg | PVT Scores by Timepoint | 3:15am | 243.6 msec | Standard Error 4.65 |
| SPD489 20 mg | PVT Scores by Timepoint | 5:15am | 253.4 msec | Standard Error 4.67 |
| SPD489 50 mg | PVT Scores by Timepoint | 5:15am | 237.7 msec | Standard Error 4.66 |
| SPD489 50 mg | PVT Scores by Timepoint | 3:15am | 227.4 msec | Standard Error 4.64 |
| SPD489 50 mg | PVT Scores by Timepoint | 11:15pm | 230.9 msec | Standard Error 2.97 |
| SPD489 50 mg | PVT Scores by Timepoint | 9:15pm | 233.2 msec | Standard Error 3.49 |
| SPD489 50 mg | PVT Scores by Timepoint | 7:15am | 242.6 msec | Standard Error 7.67 |
| SPD489 50 mg | PVT Scores by Timepoint | 1:15am | 231.5 msec | Standard Error 3.88 |
| SPD489 50 mg | PVT Scores by Timepoint | 9:15am | 240.0 msec | Standard Error 10.84 |
| SPD489 70 mg | PVT Scores by Timepoint | 3:15am | 240.7 msec | Standard Error 4.64 |
| SPD489 70 mg | PVT Scores by Timepoint | 9:15pm | 234.9 msec | Standard Error 3.49 |
| SPD489 70 mg | PVT Scores by Timepoint | 11:15pm | 231.2 msec | Standard Error 2.97 |
| SPD489 70 mg | PVT Scores by Timepoint | 1:15am | 230.2 msec | Standard Error 3.89 |
| SPD489 70 mg | PVT Scores by Timepoint | 5:15am | 242.5 msec | Standard Error 4.66 |
| SPD489 70 mg | PVT Scores by Timepoint | 7:15am | 259.2 msec | Standard Error 7.67 |
| SPD489 70 mg | PVT Scores by Timepoint | 9:15am | 265.9 msec | Standard Error 10.84 |
| Armodafinil 250 mg | PVT Scores by Timepoint | 1:15am | 233.0 msec | Standard Error 3.88 |
| Armodafinil 250 mg | PVT Scores by Timepoint | 5:15am | 249.5 msec | Standard Error 4.66 |
| Armodafinil 250 mg | PVT Scores by Timepoint | 11:15pm | 229.3 msec | Standard Error 2.97 |
| Armodafinil 250 mg | PVT Scores by Timepoint | 9:15am | 256.7 msec | Standard Error 10.93 |
| Armodafinil 250 mg | PVT Scores by Timepoint | 7:15am | 259.1 msec | Standard Error 7.67 |
| Armodafinil 250 mg | PVT Scores by Timepoint | 9:15pm | 235.5 msec | Standard Error 3.49 |
| Armodafinil 250 mg | PVT Scores by Timepoint | 3:15am | 242.5 msec | Standard Error 4.64 |
| Placebo | PVT Scores by Timepoint | 1:15am | 256.7 msec | Standard Error 3.89 |
| Placebo | PVT Scores by Timepoint | 9:15am | 276.1 msec | Standard Error 10.84 |
| Placebo | PVT Scores by Timepoint | 7:15am | 295.5 msec | Standard Error 7.67 |
| Placebo | PVT Scores by Timepoint | 5:15am | 291.6 msec | Standard Error 4.67 |
| Placebo | PVT Scores by Timepoint | 11:15pm | 249.3 msec | Standard Error 2.98 |
| Placebo | PVT Scores by Timepoint | 9:15pm | 241.3 msec | Standard Error 3.5 |
| Placebo | PVT Scores by Timepoint | 3:15am | 280.7 msec | Standard Error 4.65 |
Comparison: 9:15pmp-value: 0.054495% CI: [-19.4, 0.2]Mixed Models Analysis
Comparison: 9:15pmp-value: 0.44195% CI: [-13.6, 6]Mixed Models Analysis
Comparison: 9:15pmp-value: 0.104695% CI: [-17.9, 1.7]Mixed Models Analysis
Comparison: 9:15pmp-value: 0.646795% CI: [-12, 7.5]Mixed Models Analysis
Comparison: 9:15pmp-value: 0.197195% CI: [-16.2, 3.4]Mixed Models Analysis
Comparison: 9:15pmp-value: 0.905295% CI: [-10.4, 9.2]Mixed Models Analysis
Comparison: 9:15pmp-value: 0.24295% CI: [-15.6, 4]Mixed Models Analysis
Comparison: 11:15pmp-value: 0.000195% CI: [-25.1, -8.3]Mixed Models Analysis
Comparison: 11:15pmp-value: 0.432195% CI: [-5, 11.6]Mixed Models Analysis
Comparison: 11:15pmp-value: <0.000195% CI: [-26.7, -10.1]Mixed Models Analysis
Comparison: 11:15pmp-value: 0.699995% CI: [-6.7, 9.9]Mixed Models Analysis
Comparison: 11:15pmp-value: <0.000195% CI: [-26.4, -9.8]Mixed Models Analysis
Comparison: 11:15pmp-value: 0.656695% CI: [-6.4, 10.2]Mixed Models Analysis
Comparison: 11:15pmp-value: <0.000195% CI: [-28.3, -11.7]Mixed Models Analysis
Comparison: 1:15amp-value: <0.000195% CI: [-36.1, -14.3]Mixed Models Analysis
Comparison: 1:15amp-value: 0.782495% CI: [-12.4, 9.4]Mixed Models Analysis
Comparison: 1:15amp-value: <0.000195% CI: [-36, -14.3]Mixed Models Analysis
Comparison: 1:15amp-value: 0.786795% CI: [-12.4, 9.4]Mixed Models Analysis
Comparison: 1:15amp-value: <0.000195% CI: [-37.4, -15.6]Mixed Models Analysis
Comparison: 1:15amp-value: 0.602995% CI: [-13.7, 8]Mixed Models Analysis
Comparison: 1:15amp-value: <0.000195% CI: [-34.5, -12.8]Mixed Models Analysis
Comparison: 3:15amp-value: <0.000195% CI: [-50.1, -24.1]Mixed Models Analysis
Comparison: 3:15amp-value: 0.868495% CI: [-11.9, 14.1]Mixed Models Analysis
Comparison: 3:15amp-value: <0.000195% CI: [-66.3, -40.3]Mixed Models Analysis
Comparison: 3:15amp-value: 0.022895% CI: [-28.1, -2.1]Mixed Models Analysis
Comparison: 3:15amp-value: <0.000195% CI: [-53, -27]Mixed Models Analysis
Comparison: 3:15amp-value: 0.785295% CI: [-14.8, 11.2]Mixed Models Analysis
Comparison: 3:15amp-value: <0.000195% CI: [-51.2, -25.2]Mixed Models Analysis
Comparison: 5:15amp-value: <0.000195% CI: [-51.3, -25.1]Mixed Models Analysis
Comparison: 5:15amp-value: 0.552895% CI: [-9.1, 17]Mixed Models Analysis
Comparison: 5:15amp-value: <0.000195% CI: [-67, -40.9]Mixed Models Analysis
Comparison: 5:15amp-value: 0.074795% CI: [-24.9, 1.2]Mixed Models Analysis
Comparison: 5:15amp-value: <0.000195% CI: [-62.2, -36.1]Mixed Models Analysis
Comparison: 5:15amp-value: 0.286895% CI: [-20.1, 6]Mixed Models Analysis
Comparison: 5:15amp-value: <0.000195% CI: [-55.2, -29.1]Mixed Models Analysis
Comparison: 7:15amp-value: 0.000795% CI: [-59.1, -16.2]Mixed Models Analysis
Comparison: 7:15amp-value: 0.908995% CI: [-22.7, 20.2]Mixed Models Analysis
Comparison: 7:15amp-value: <0.000195% CI: [-74.3, -31.4]Mixed Models Analysis
Comparison: 7:15amp-value: 0.130795% CI: [-37.9, 5]Mixed Models Analysis
Comparison: 7:15amp-value: 0.001195% CI: [-57.7, -14.8]Mixed Models Analysis
Comparison: 7:15amp-value: 0.990395% CI: [-21.3, 21.6]Mixed Models Analysis
Comparison: 7:15amp-value: 0.00195% CI: [-57.8, -14.9]Mixed Models Analysis
Comparison: 9:15amp-value: 0.165595% CI: [-51.7, 9]Mixed Models Analysis
Comparison: 9:15amp-value: 0.897595% CI: [-32.4, 28.5]Mixed Models Analysis
Comparison: 9:15amp-value: 0.019995% CI: [-66.5, -5.8]Mixed Models Analysis
Comparison: 9:15amp-value: 0.278595% CI: [-47.2, 13.7]Mixed Models Analysis
Comparison: 9:15amp-value: 0.504895% CI: [-40.6, 20.1]Mixed Models Analysis
Comparison: 9:15amp-value: 0.553395% CI: [-21.3, 39.6]Mixed Models Analysis
Comparison: 9:15amp-value: 0.209895% CI: [-49.9, 11.1]Mixed Models Analysis