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

Phase 4

Completed

• Conditions: Neurofibromatosis Type 1

• Registration Number: NCT00169611
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-26
• Last Update Posted: 2011-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Effect of methylphenidate compared to placebo on ADHD. Time of measurements are realised on day 0, day 28, day 63 + 2 days.

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of methylphenidate compared to placebo on specific neuropsychologic, depression and anxiety scales
To compare the nature of attention deficit disorders in NF1 children with those with primary ADHD, depression, and anxiety using the State Trait Anxiety Inventory for Children (STAI-C) and the Children's Depression Inventory (CDI).
Time of measurements are realised on day 0, day 28, day 63 + 2 days.

Trial Locations

Locations (1)

Laurence LION-FRANCOIS; 🇫🇷 Lyon, France