At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
SPD489drug
Likely dose
SPD489 5mgfrom 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, Open-label, Multicenter, Exploratory Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder
In Brief
A Phase 2 clinical trial evaluating SPD489 for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 24 participants across 6 sites.
Detailed Summary
The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartApr 2015
Primary CompletionJun 2016
TodayJul 2026
First PostedMar 30, 2015
Enrollment StartApr 15, 2015
Primary CompletionJun 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.3 years ago
Interventions
SPD489drug
All subjects will begin with 5mg of SPD489 daily and will be titrated until optimal dose is reached (5, 10, 15, 20, and 30mg)