CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 7 enrolled
Drug / intervention
methylphenidatedrug
Likely dose
methylphenidate 2.5mgfrom 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.

Search/NCT00754208
NCT00754208Phase 4Completed
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Long Acting Stimulant Treatment of ADHD in Young Children

University of Nebraska·interventional·Posted Sep 17, 2008·Updated Oct 5, 2023

In Brief

A Phase 4 clinical trial evaluating methylphenidate for Attention Deficit Hyperactivity Disorder. Completed, enrolled 7 participants across 1 site.

Detailed Summary

This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Virtually no data has been published on the use of long-acting stimulant preparations in very young children despite early symptomatic development in a significant portion of young children with ADHD. This would be one of the first studies looking at a long-acting preparation of a stimulant medication in the treatment of ADHD in very young children. Hypotheses 1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children. 2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 17, 2008
Enrollment StartSep 18, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.8 years ago

Interventions

methylphenidatedrug

Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.