CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 146 enrolled
Drug / intervention
Lovastatin ™ +1 moredrug
Likely dose
Lovastatin ™ 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00853580
NCT00853580Phase 2Completed
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A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1

University of Alabama at Birmingham·interventional·Posted Mar 2, 2009·Updated Mar 12, 2018

In Brief

A Phase 2 clinical trial evaluating Lovastatin ™ and placebo for Neurofibromatosis Type 1. Completed, enrolled 146 participants across 12 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurofibromatosis Type 1
CountriesAustralia, United States
CollaboratorsBoston Children's Hospital, Children's Hospital of Philadelphia, Children's National Research Institute, Children's Hospital Medical Center, Cincinnati, National Cancer Institute (NCI), University of Chicago, University of Utah, Washington University School of Medicine, Sydney Children's Hospitals Network, University of Texas Southwestern Medical Center

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2009
Enrollment StartJul 1, 2009
Primary CompletionMay 1, 2014
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.3 years ago

Interventions

Lovastatin ™drug

Lovastatin starting at 20mg for 2 weeks, increasing to 40mg for 14 weeks. Total duration of trial is 16 weeks.

placebodevice

Starting at 20mg for 2 weeks, then increasing to 40mg for 14 additional weeks for a total duration of treatment of 16 weeks.