Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo
Phase 4
7 Years
12 Years
7 Years
12 Years
Not Enrolling
Both
Neurofibromatosis Type 1
Both
Neurofibromatosis Type 1
Trial Information
Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo
Inclusion Criteria:
- Age 7-12 years
- IQ between 80-120.
- Gender: male or female
- Children with neurofibromatosis type 1 (according to the National Institutes of
Health [NIH] 1988).
- Patients with school difficulties pointed out by parents or teachers
- Patients with attention difficulties as defined by anamnesis
Exclusion Criteria:
- IQ > 120 or IQ < 80
- Child depression
- Unwillingness to participate
- Patients with cerebral complication of neurofibromatosis type 1 (chiasma glioma,
moya-moya) as detected by cerebral magnetic resonance imaging (MRI).
- Participation in another study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind
Outcome Measure:
Effect of methylphenidate compared to placebo on ADHD. Time of measurements are realised on day 0, day 28, day 63 + 2 days.
Principal Investigator
Laurence LION-FRANCOIS, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Service de Neuropédiatrie - Hôpital Femme Mère Enfant - Hospices Civils de Lyon - 59 bd Pinel - 69677 BRON - France
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2003.310
NCT ID:
NCT00169611
Start Date:
January 2004
Completion Date:
January 2011
Related Keywords:
- Neurofibromatosis Type 1
- Neurofibromatosis type 1
- Attention deficit with hyperactivity disorder school difficulties
- methylphenidate
- Neurofibromatoses
- Neurofibromatosis 1
- Osteitis Fibrosa Cystica
Name | Location |
|---|
