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

Neurofibromatosis Type 1 Clinical Trial

Official title:

Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169611
• Other study ID #: 2003.310
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: January 26, 2011
• Start date: January 2004
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis Type 1

Intervention

Drug:
• methylphenidate

Locations

Country	Name	City	State
France	Laurence LION-FRANCOIS	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of methylphenidate compared to placebo on ADHD. Time of measurements are realised on day 0, day 28, day 63 + 2 days.
Secondary	To evaluate the efficacy of methylphenidate compared to placebo on specific neuropsychologic, depression and anxiety scales
Secondary	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).
Secondary	Time of measurements are realised on day 0, day 28, day 63 + 2 days.

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