Dettagli per singolo studio

DEC-NET Serial number FR547

Published online	10/07/2006 17.05.00
Last updated	10/07/2006 17.05.21

Other protocol ID number	N/A
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	NEUROFIBROMATOSIS TYPE 1 VON RECKLINGHAUSEN
Experimental drug
Methylphenidate Treatment regimen (dosage and duration) Treatment starts by 0.5 mg/kg per os. Posology is reached gradually until 0.8 mg/kg/day.
Gender	Both
Age (range)	7-12 years
Eligibility criteria
Inclusion criteria
-Age 7-12 years -120 > Intelligence quotient > 80 -Children with neurofibromatosis type 1 -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 -Patient under psychotropic treatment -Patients with cerebral complication of neurofibromatosis type 1 (tumor, cerebrovascular accident,chiasma glioma,moya-moya,) -Unwillingness to participate
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind Cross-over
Purpose of study
Primary objective: -To evaluate the efficacy of methylphenidate compared to placebo on specific neuropsychologic, depression and anxiety scales Secondary objective: -To compare the nature of attention deficit disorders in NF1 children with those with primary Attention Deficit Hyperactivity Disorder(ADHD).
Primary outcomes
Conners'Rating Scale
Secondary outcomes
-
Summary of study design, objectives, and ongoing research findings
Randomized, double blind, placebo controlled, cross over trial of children with Neurofibromatosis Type 1 with a total follow-up duration of 9 weeks to evaluate the effect of methylphenidate (MPH) on the improvement of the simplified parents Conners' Rating Scale. Children aged 7 to 12 years are eligible when their intelligence quotient (IQ) is between 80 and 120. Fifty subjects (25 for each period) were required. Primary Outcome: To evaluate the efficacy of methylphenidate compared to placebo on specific neuropsychologic, depression and anxiety scales Secondary Outcomes: To compare the nature of attention deficit disorders in NF1 children with those with primary ADHD