drugset / Trial / NCT01096680
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
RandomizedParallel-groupTriple-blindOther
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.
Timeline
- Start
- 2010-04-05
- Primary completion
- 2010-07-18
- Completion
- 2010-07-18
Outcome
Met primary endpoint
registry analysis (unspecified test); SPD489 20 mg vs Placebo; p <0.0001; Mean Difference (Final Values) 8.0 (95% CI 5.0 to 10.9); Mixed Models Analysis NCT01096680 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Armodafinil | Small molecule | 250 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 20 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 50 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 70 mg | Oral |
Indications
No indication recorded.