Phase 2
N=135
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
Sleep Deprivation
Bottom Line
View on ClinicalTrials.gov: NCT01096680 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Maintenance of Wakefulness Test (MWT) — 23.3; 27.9; 29.3; 27.6 Minutes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPD489 20 mg (Drug); SPD489 50 mg (Drug); SPD489 70 mg (Drug); Armodafinil (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Shire
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maintenance of Wakefulness Test (MWT) |
23.3; 27.9; 29.3; 27.6; 15.3 | <0.0001 sig |
| SECONDARY Karolinska Sleepiness Scale (KSS) Scores |
4.7; 4.0; 3.6; 4.7; 5.2 | 0.1123 |
| SECONDARY KSS Scores by Timepoint |
2.9; 3.0; 2.6; 2.6; 2.8; 2.7 | 0.7758 |
| SECONDARY Psychomotor Vigilance Task (PVT) Scores |
243.6; 234.8; 243.5; 243.7; 270.2 | <0.0001 sig |
| SECONDARY PVT Scores by Timepoint |
231.6; 233.2; 234.9; 235.5; 241.3; 232.6 | 0.0544 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01096680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.