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

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Brief Title

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

Official Title

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

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 To evaluate the efficacy of methylphenidate compared to placebo on specific neuropsychologic, depression and anxiety scales

Condition

Neurofibromatosis Type 1

Intervention

methylphenidate


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

January 2004

Completion Date

January 2011

Primary Completion Date

January 2011

Eligibility 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
      

Gender

All

Ages

7 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Laurence LION-FRANCOIS, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00169611

Organization ID

2003.310



Study Sponsor

Hospices Civils de Lyon


Study Sponsor

Laurence LION-FRANCOIS, MD, Principal Investigator, Service de Neuropédiatrie - Hôpital Femme Mère Enfant - Hospices Civils de Lyon - 59 bd Pinel - 69677 BRON - France


Verification Date

January 2011