drugset / Trial / NCT01096680

Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

NCT01096680

Phase 2 Completed 135 enrolled Shire
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

Drugs

EvaluationDrugModalityDoseRoute
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.