A prospective randomized placebo-controlled study to evaluate the effect of lovastatin on neuropsychological function in children with neurofibromatosis type 1

Prof Kathryn North0 个研究点目标入组 142 人开始时间: 2007年11月1日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Males or females aged between 8-15 years of age who meet National Institutes of Health (NIH) diagnostic criteria for neurofibromatosis type 1 (NF1). 2. Full scale intellectual quotient (IQ) of 70 or above. 3. Cognitive impairment defined as having a score of at least 1 standard deviation or more below the normative mean on one or more of the primary outcome measures.

•1. Full scale IQ score less than 70.
•2. Individuals with insufficient English to complete the assessments.
•3. Participants taking stimulant medication or Straterra, as it is unclear whether lovastatin and ADHD medication utilise similar biological pathways, possibly leading to an interaction between the two medications
•4. Participants on psychotropic or antiepileptic medication
•5. Participants with intracranial pathology such as epilepsy, diagnosed head injury, hydrocephalus or progressive intracranial tumors (children with asymptomatic or static lesions will be eligible).
•6. Participants who are pregnant or breastfeeding.
•7. Participants with a clinically significant unrelated illness, which in the judgement of the principle or associate investigator, would compromise the participant's ability to tolerate the medication or potentially interfere with the participant's ability to participate in the required testing.
•8. Children with very low LDL cholesterol levels pre-treatment (1 mmol/L). LDL levels within the normal range are required pre-treatment as lovastatin has been shown to lower levels of LDL cholesterol by approximately 30%.

发起方

Prof Kathryn North