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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169611

Enrollment

Registered

2005-09-15

Start date

2004-01-31

Completion date

2011-01-31

Last updated

2011-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis Type 1

Keywords

Neurofibromatosis type 1, Attention deficit with hyperactivity disorder school difficulties, methylphenidate

Brief 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.

Interventions

DRUGmethylphenidate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

7 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect of methylphenidate compared to placebo on ADHD. Time of measurements are realised on day 0, day 28, day 63 + 2 days.	—

Secondary

Measure	Time frame
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.	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026