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

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00169611

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 IV

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies neurofibromatosis type 1 neurofibromatosis type 2

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Hospice Care Neurofibromatosis

Drug Information available for: Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

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

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

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

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

Contacts

Contact: Laurence LION-FRANCOIS, MD

33 4 72 38 55 54

laurence.francois@chu-lyon.fr

Locations

France
Laurence LION-FRANCOIS	Recruiting
Lyon, France, 69005
Contact: Laurence LION-FRANCOIS, MD 33 4 72 38 55 54 laurence.francois@chu-lyon.fr

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Laurence LION-FRANCOIS, MD

Hospices Civils de Lyon

More Information

Related Info This link exits the ClinicalTrials.gov site

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

Keywords provided by Hospices Civils de Lyon:

Neurofibromatosis type 1
Attention deficit with hyperactivity disorder school difficulties
methylphenidate

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009