At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 113 enrolled
Drug / intervention
SPD489drug
Likely dose
SPD489 5 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, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed With Attention-deficit / Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating SPD489 for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 113 participants across 50 sites.
Detailed Summary
The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartAug 2015
Primary CompletionJan 2020
TodayJul 2026
First PostedJun 9, 2015
Enrollment StartAug 21, 2015
Primary CompletionJan 3, 2020
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.1 years ago
Interventions
SPD489drug
Participants will receive 5 mg of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached.