The effect of long-term simvastatin treatment on cognitive function and daily life in children with Neurofibromatosis 1: a one year randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010965-22-NL

Enrollment

106

Registered

2009-09-21

Start date

2009-09-29

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis 1

Interventions

Product Name: SIMVASTATIN Product Code: SIMVASTATIN Pharmaceutical Form: Capsule* INN or Proposed INN: SIMVASTATIN CAS Number: 79902639 Concentration unit: mg milligram(s) Concentration type: range Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 - WISC III-R Behavioral Problems on the Child Behavioral Checklist (CBCL) - Internalizing behavioral problems - Attention problems	—

Measure

Time frame

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 - WISC III-R Behavioral Problems on the Child Behavioral Checklist (CBCL) - Internalizing behavioral problems - Attention problems

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026