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NCT00853580 · ClinicalTrials.gov registry record · Phase 2
A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 146
- Enrollment target
NCT00853580: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT00853580 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 146 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853580, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 146 participants
- Enrollment target
Study Summary
The specific aim of this study is to determine whether Lovastatin ™ significantly improves visual spatial learning and/or sustained attention in children with NF1. Secondary Aims: To evaluate the effect of Lovastatin ™ on measures of executive function, behavior and quality of life in children with NF1 and cognitive deficits. To further evaluate the toxicity and tolerability of Lovastatin ™ in children with NF1 and cognitive deficits. Hypotheses It is hypothesized that Lovastatin ™ will improve the visual spatial memory and/or attention deficits in children with NF1. This is based on studies demonstrating that Lovastatin ™ has significantly improved impairments in visual spatial memory and attention in the NF1 murine model. It is further expected that Lovastatin ™ will be safe and well tolerated over a 16-week period.
Primary Outcome
A computerized test of visuospatial learning. Participants had to remember patterns associated with different locations on the screen, and during the test phase, as each pattern is presented, point to the appropriate location. The test starts at a very simple level and gradually increases in difficulty. Higher number of errors indicates poorer performance. Scale does not have a maximum range.
Interventions
- DEVICE placebo
- DRUG Lovastatin ™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2009-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00853580 record still lists
NCT00853580 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00853580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853580 about?
NCT00853580 is a clinical study titled "A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1". The specific aim of this study is to determine whether Lovastatin ™ significantly improves visual spatial learning and/or sustained attention in children with NF1. Secondary Aims: To evaluate the effect of Lovastatin ™ on measures of executive function, behavior and quality of life in children wit...
What is the current status of trial NCT00853580?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2009-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00853580?
The interventions under investigation include: placebo (DEVICE), Lovastatin ™ (DRUG).
Who is sponsoring clinical trial NCT00853580?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853580's enrollment target sits among peer trials
146 496th of 2000 higher than 1,503 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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