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Brief Title: NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate
Official Title: Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo
Study ID: NCT00169611
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:
Minimum Age: 7 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Laurence LION-FRANCOIS, Lyon, , France
Name: Laurence LION-FRANCOIS, MD
Affiliation: Service de Neuropédiatrie - Hôpital Femme Mère Enfant - Hospices Civils de Lyon - 59 bd Pinel - 69677 BRON - France
Role: PRINCIPAL_INVESTIGATOR
Name: Isabelle KEMLIN
Affiliation: Service de Neuropédiatrie - Hôpital Armand Trousseau - PARIS - France
Role: PRINCIPAL_INVESTIGATOR