The effect of long-term simvastatin treatment on cognitive function and daily life in children with Neurofibromatosis 1: a one year randomized controlled trial
- Conditions
- eurofibromatosis 1
- Registration Number
- EUCTR2009-010965-22-NL
- Lead Sponsor
- Erasmus MC - Department of Pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 106
Inclusion criteria are: age 8 to 16 years, NF1 diagnosis with genetic confirmation, and oral and written informed consent from parents and participants aged older than 12 years.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria are: segmental NF1, pathology of the CNS (other than asymptomatic gliomas), deafness, severely impaired vision, use of ADHD-medication, use of anti-epileptic drugs, use of simvastatin, use of anti-psychotic medication, insufficient comprehension or production of the Dutch language, and an IQ below 48.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to determine the effect of long-term simvastatin treatment in NF1 children on cognitive function (IQ) and behavioral problems (both internalizing problems and attention).;Secondary Objective: The secondary objective of this study is to determine the effect of long-term simvastatin treatment in NF1 children on school performance, health related quality of life, behavior (other), cognition (other) and fine motor coordination.;Primary end point(s): Cognitive Function<br>- WISC III-R<br>Behavioral Problems on the Child Behavioral Checklist (CBCL)<br>- Internalizing behavioral problems <br>- Attention problems<br>
- Secondary Outcome Measures
Name Time Method