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

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00169611
First received: September 9, 2005
Last updated: January 26, 2011
Last verified: January 2011
  Purpose

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)
  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169611

Locations
France
Laurence LION-FRANCOIS
Lyon, France, 69005
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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:
No publications provided

Responsible Party: Dr Laurence LION-FRANCOIS, Service de Neuropédiatrie - Hôpital Femme Mère Enfant -
ClinicalTrials.gov Identifier: NCT00169611     History of Changes
Other Study ID Numbers: 2003.310
Study First Received: September 9, 2005
Last Updated: January 26, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibromatosis 1
Osteitis Fibrosa Cystica
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014