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Sponsored by: |
Hospices Civils de Lyon |
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Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00169611 |
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.
Condition | Intervention | Phase |
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Neurofibromatosis Type 1 |
Drug: methylphenidate |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Crossover Assignment |
Official Title: | Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-Blind Randomised Study Methylphenidate Versus Placebo |
Estimated Enrollment: | 80 |
Study Start Date: | January 2004 |
Ages Eligible for Study: | 7 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurence LION-FRANCOIS, MD | 33 4 72 38 55 54 | laurence.francois@chu-lyon.fr |
France | |
Laurence LION-FRANCOIS | Recruiting |
Lyon, France, 69005 | |
Contact: Laurence LION-FRANCOIS, MD 33 4 72 38 55 54 laurence.francois@chu-lyon.fr |
Principal Investigator: | Laurence LION-FRANCOIS, MD | Hospices Civils de Lyon |
Study ID Numbers: | 2003.310 |
Study First Received: | September 9, 2005 |
Last Updated: | October 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00169611 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Neurofibromatosis type 1 Attention deficit with hyperactivity disorder school difficulties methylphenidate |
Methylphenidate Neurodegenerative Diseases Neurofibromatosis 1 Neurofibromatosis type 1 Dopamine Neoplastic Syndromes, Hereditary Heredodegenerative Disorders, Nervous System Neurofibroma |
Genetic Diseases, Inborn Neuromuscular Diseases Peripheral Nervous System Diseases Neurofibromatoses Hyperkinesis Nerve Sheath Neoplasms Neurocutaneous Syndromes |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Nerve Tissue Nervous System Diseases |
Physiological Effects of Drugs Central Nervous System Stimulants Pharmacologic Actions Neoplasms Therapeutic Uses Dopamine Agents Central Nervous System Agents |