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NCT00564954 · ClinicalTrials.gov registry record · Phase 4
A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 86
- Enrollment target
NCT00564954: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00564954 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 86 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00564954, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 86 participants
- Enrollment target
Study Summary
This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
Primary Outcome
SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.
Interventions
- DRUG Placebo
- DRUG Dex-methylphenidate hydrochloride extended-release (Focalin XR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2007-10 |
| Est. Completion | 2007-11 |
| Phase | Phase 4 |
What the finished NCT00564954 record still lists
NCT00564954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00564954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00564954 about?
NCT00564954 is a clinical study titled "A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)". This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
What is the current status of trial NCT00564954?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 86 participants. The study started on 2007-10. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00564954?
The interventions under investigation include: Placebo (DRUG), Dex-methylphenidate hydrochloride extended-release (Focalin XR) (DRUG).
Who is sponsoring clinical trial NCT00564954?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00564954's enrollment target sits among peer trials
86 926th of 2000 higher than 1,073 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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