Status:
COMPLETED
Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)
Lead Sponsor:
University of California, Los Angeles
Conditions:
Neurofibromatosis 1
Eligibility:
All Genders
10-50 years
Phase:
PHASE1
Brief Summary
Neurofibromatosis type I (NF1) is a genetic disorder that affects approximately 1 in 3500 individuals. Half of people with NF1 inherit the condition from a parent, and half have a new occurrence of th...
Eligibility Criteria
Inclusion
- a diagnosis of NF1 by NIH criteria
- between 10 and 50 years of age
- no evidence of a comorbid neurological disorder (e.g., epilepsy, encephalitis)
- not currently taking a statin medication
- 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)
- 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.
- not mentally retardation (i.e., IQ greater than 70)
- no evidence of significant and habitual alcohol or drug abuse or dependence
- sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder, and verbal abilities.
- lives in Southern California area (or can arrange \~5 visits to Los Angeles over 14 weeks)
Exclusion
- comorbid neurological conditions
- significant drug or alcohol abuse
- non-fluency in English
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00352599
Start Date
September 1 2009
End Date
March 1 2014
Last Update
November 22 2016
Active Locations (1)
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1
Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States, 90095