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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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27 January 2014 |
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Main ID: |
EUCTR2009-010965-22-NL |
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Date of registration:
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21/09/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of long-term simvastatin treatment on cognitive function and daily life in children with Neurofibromatosis 1: a one year randomized controlled trial
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Scientific title:
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The effect of long-term simvastatin treatment on cognitive function and daily life in children with Neurofibromatosis 1: a one year randomized controlled trial |
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Date of first enrolment:
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29/09/2009 |
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Target sample size:
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106 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010965-22 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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 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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Neurofibromatosis 1
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Intervention(s)
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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
Concentration number: 10-40
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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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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.
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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).
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Secondary ID(s)
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NF1-SIMCODA
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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