Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)

• 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
• 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)

tolerability of medication [Time Frame: 14 weeks]

attention [Time Frame: 14 weeks]

Secondary ID(s)

05-08-069-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors