At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 199 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
SPD489 (Lisdexamfetamine dimesylate) 30 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 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-Dose Safety and Efficacy Study of SPD489 Compared With Placebo in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating Placebo, SPD489 (Lisdexamfetamine dimesylate), and 1 other intervention for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 199 participants across 48 sites.
Detailed Summary
The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionOct 2018
TodayJul 2026
First PostedAug 24, 2017
Enrollment StartSep 6, 2017
Primary CompletionOct 23, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.9 years ago
Interventions
Placebodrug
Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.
SPD489 (Lisdexamfetamine dimesylate)drug
SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.
SPD489drug
SPD489