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NCT00754208 · ClinicalTrials.gov registry record · Phase 4
Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children
A Phase 4 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 4
- Development phase
- 7
- Enrollment target
NCT00754208: Completed Phase 4 study, sponsored by University of Nebraska.
NCT00754208 is a Phase 4 study that has completed, run by University of Nebraska. The registered enrollment target is 7 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00754208, a Phase 4 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 7 participants
- Enrollment target
Study 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.
Primary Outcome
Change from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline. Higher scores indicate greater symptom severity.
Interventions
- DRUG methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2008-09-18 |
| Est. Completion | 2010-01-01 |
| Phase | Phase 4 |
What the finished NCT00754208 record still lists
NCT00754208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which methylphenidate is the first listed.
NCT00754208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00754208 about?
NCT00754208 is a clinical study titled "Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children". 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 ea...
What is the current status of trial NCT00754208?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 7 participants. The study started on 2008-09-18. Estimated completion is 2010-01-01.
What interventions are being tested in trial NCT00754208?
The interventions under investigation include: methylphenidate (DRUG).
Who is sponsoring clinical trial NCT00754208?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00754208's enrollment target sits among peer trials
7 1981st of 2000 higher than 18 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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