NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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.