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This study evaluates the safety of Lovastatin, compared with a placebo (inactive pill), in individuals with neurofibromatosis type 1 (NF1). People aged 10 to 50 who had been diagnosed with NF1 by NIH criteria were able to take part. Sponsored by the University of California, Los Angeles, the study was conducted in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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