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

This study has been completed.
Information provided by:
Hospices Civils de Lyon Identifier:
First received: September 9, 2005
Last updated: January 26, 2011
Last verified: January 2011
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
Neurofibromatosis Type 1
Drug: methylphenidate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 80
Study Start Date: January 2004
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00169611

Lyon, France, 69005
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Laurence LION-FRANCOIS, MD Service de Neuropédiatrie - Hôpital Femme Mère Enfant - Hospices Civils de Lyon - 59 bd Pinel - 69677 BRON - France
Principal Investigator: Isabelle KEMLIN Service de Neuropédiatrie - Hôpital Armand Trousseau - PARIS - France
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Laurence LION-FRANCOIS, Service de Neuropédiatrie - Hôpital Femme Mère Enfant - Identifier: NCT00169611     History of Changes
Other Study ID Numbers: 2003.310
Study First Received: September 9, 2005
Last Updated: January 26, 2011

Keywords provided by Hospices Civils de Lyon:
Neurofibromatosis type 1
Attention deficit with hyperactivity disorder school difficulties

Additional relevant MeSH terms:
Neurofibromatosis 1
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on May 25, 2017