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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status and phase

Completed
Phase 4

Conditions

Neurofibromatosis Type 1

Treatments

Drug: methylphenidate

Study type

Interventional

Funder types

Other

Identifiers

NCT00169611
2003.310

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

7 to 12 years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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