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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Plac

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 Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: Effect of methylphenidate compared to placebo on ADHD. Time of measurements are realised on day 0, day 28, day 63 + 2 days.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • 1) To evaluate the efficacy of methylphenidate compared to placebo on specific neuropsychologic, depression and anxiety scales
  • 2) to compare the nature of attention deficit disorders in NF1 children with those with primary ADHD Depression and anxiety STAI-C, CDI.
  • Time of measurements are realised on day 0, day 28, day 63 + 2 days.


Information By: Hospices Civils de Lyon

Dates:
Date Received: September 9, 2005
Date Started: January 2004
Date Completion:
Last Updated: January 26, 2011
Last Verified: January 2011