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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 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 146 participants.
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.
Interventions
- DEVICE placebo
- DRUG Lovastatin ™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2009-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00853580
The ClinicalTrials.gov registry entry for NCT00853580 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00853580 reports 0 study locations.
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.
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