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CompletedNCT00141050Updated Dec 21, 2007

Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

A Phase 3 interventional study of Focalin XR in ADHD, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2007-12-21.

Sponsored by Novartis · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.

02

Conditions studied

  • ADHD

Keywords

  • ADHD, children
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's enrollment of 90 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • DSM-IV diagnosis of ADHD
  • Males and females aged 6-12

Exclusion criteria

Exclusion Criteria:

  • Inability to understand or follow instructions
  • Is pregnant
  • Diagnosis of tic disorder
  • History of seizure disorder
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
90 participants

Interventions

  • DrugFocalin XR
06

What researchers measure

Primary outcomes

  1. Change in attention and deportment measured at 2 hours post-dose

Secondary outcomes

  1. Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose

  2. Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline

  3. Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.

07

Study locations

1 site
  • Bayou City Research
    Houston, Texas 77007, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00141050
Lead sponsor
Novartis
First posted
Sep 1, 2005
Start date
May 2005
Completion
Jul 2005
Last update
Dec 21, 2007

Study contacts

Matthew Brams, MD
principal investigator · Bayou City Research
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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