At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 165 enrolled
Drug / intervention
Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) +1 moredrug
Likely dose
Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) 10 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, Placebo-controlled, Cross-over Study Evaluating the Safety and Efficacy of Dex-Methylphenidate Extended Release 30 mg vs. 20 mg as Measured by SKAMP-Combined Scores in Children 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 (ADHD). Completed, enrolled 165 participants across 8 sites.
Detailed Summary
This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedOct 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedOct 20, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.7 years ago
Interventions
Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)drug
10 mg and/or 20 mg capsules
Placebodrug
Placebo Comparator