At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 86 enrolled
Drug / intervention
Dex-methylphenidate hydrochloride extended-release (Focalin XR) +1 moredrug
Likely dose
Dex-methylphenidate hydrochloride extended-release (Focalin XR) 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 Randomized, Multi-center, Double-blind, Cross-over Study Comparing the Efficacy and Safety of Focalin® XR 20 mg Versus Placebo at the 0.5 Hour Timepoint (Post-dose) in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting
In Brief
A Phase 4 clinical trial evaluating Dex-methylphenidate hydrochloride extended-release (Focalin XR) and Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 86 participants across 5 sites.
Detailed Summary
This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
Primary CompletionNov 2007
First PostedNov 2007
TodayJul 2026
First PostedNov 29, 2007
Enrollment StartOct 1, 2007
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 18.6 years ago
Interventions
Dex-methylphenidate hydrochloride extended-release (Focalin XR)drug
20 mg capsule orally once a day for 7 days
Placebodrug
orally once a day for 7 days