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

Civil Hospices of Lyon

Status and phase: Completed; Phase 4

Conditions: Neurofibromatosis Type 1

Treatments: Drug: methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT00169611

2003.310

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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