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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 28 November 2016
Main ID:  NCT00352599
Date of registration: 13/07/2006
Prospective Registration: Yes
Primary sponsor: University of California, Los Angeles
Public title: Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1) NF1
Scientific title: Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)
Date of first enrolment: September 2009
Target sample size: 44
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00352599
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Carrie E Bearden, PhD
Address: 
Telephone:
Email:
Affiliation:  University of California, Los Angeles
Key inclusion & exclusion criteria

Inclusion Criteria:

1. a diagnosis of NF1 by NIH criteria

2. between 10 and 50 years of age

3. no evidence of a comorbid neurological disorder (e.g., epilepsy, encephalitis)

4. not currently taking a statin medication

5. not suffering from hypercholesterolemia based on self-report, collateral information
from physician, or initial medical workup using National Cholesterol Education
Program (NCEP, JAMA 2001), guidelines accepted by the American College of Cardiology
(ACC) and the American Heart Association (AHA)

6. does not have any of the aforementioned conditions that contraindicates use of statin
medications (such as pregnancy, lactation, liver disease, or use of other medication
not recommended for use in conjunction with lovastatin). A negative pregnancy test
will be required if the patient is a female in reproductive years.

7. not mentally retardation (i.e., IQ greater than 70)

8. no evidence of significant and habitual alcohol or drug abuse or dependence

9. sufficient acculturation and fluency in the English language to avoid invalidating
research measures of thought, language, and speech disorder, and verbal abilities.

10. lives in Southern California area (or can arrange ~5 visits to Los Angeles over 14
weeks)

Exclusion Criteria:

1. comorbid neurological conditions

2. significant drug or alcohol abuse

3. non-fluency in English



Age minimum: 10 Years
Age maximum: 50 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Neurofibromatosis 1
Intervention(s)
Drug: Lovastatin
Drug: placebo pill
Primary Outcome(s)
Non-verbal learning /working memory [Time Frame: 14 weeks]
Secondary Outcome(s)
attention [Time Frame: 14 weeks]
tolerability of medication [Time Frame: 14 weeks]
Secondary ID(s)
05-08-069-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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