At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 135 enrolled
Drug / intervention
SPD489 20 mg +4 moredrug
Likely dose
SPD489 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss
In Brief
A Phase 2 clinical trial evaluating SPD489 20 mg, SPD489 50 mg, and 3 other interventions for Sleep Deprivation. Completed, enrolled 135 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Deprivation
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartApr 2010
Primary CompletionJul 2010
TodayJul 2026
First PostedMar 31, 2010
Enrollment StartApr 5, 2010
Primary CompletionJul 18, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.3 years ago
Interventions
SPD489 20 mgdrug
Single oral dose of 20 mg
SPD489 50 mgdrug
Single oral dose of 50 mg
SPD489 70 mgdrug
Single oral dose of 70 mg
Armodafinildrug
Single oral dose of 250 mg
Placebodrug
Single oral dose