NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2011-01-31

Brief Summary

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Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder with an estimated prevalence of 1/2190 to 1/6711. Attention deficit hyperactivity disorder (ADHD) has been reported to be common in NF1. We, the researchers at Hospices Civils de Lyon, designed a randomized, double blind, placebo controlled, crossover trial with a total follow-up duration of 9 weeks to evaluate the effect of methylphenidate (MPH) on the improvement on the simplified parents Conners' Rating Scale. In a parallel exploratory study we will compare the nature of attention deficit disorders in NF1 children to 30 ADHD NF1-free controls. 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 for testing the primary study hypothesis.

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Detailed Description

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Conditions

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Neurofibromatosis Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Interventions

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methylphenidate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No