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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Methylphenidate

Criteria

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