NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate
This study has been completed.
Sponsor:
Hospices Civils de Lyon
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00169611
First received: September 9, 2005
Last updated: January 26, 2011
Last verified: January 2011
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind |
| Official Title: | Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo |
Resource links provided by NLM:
MedlinePlus related topics:
Anxiety
Attention Deficit Hyperactivity Disorder
Hospice Care
Neurofibromatosis
U.S. FDA Resources
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 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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
Locations
| France | |
| Laurence LION-FRANCOIS | |
| Lyon, France, 69005 | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Laurence LION-FRANCOIS, MD | Service de Neuropédiatrie - Hôpital Femme Mère Enfant - Hospices Civils de Lyon - 59 bd Pinel - 69677 BRON - France |
| Principal Investigator: | Isabelle KEMLIN | Service de Neuropédiatrie - Hôpital Armand Trousseau - PARIS - France |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Laurence LION-FRANCOIS, Service de Neuropédiatrie - Hôpital Femme Mère Enfant - |
| ClinicalTrials.gov Identifier: | NCT00169611 History of Changes |
| Other Study ID Numbers: | 2003.310 |
| Study First Received: | September 9, 2005 |
| Last Updated: | January 26, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
Neurofibromatosis type 1 Attention deficit with hyperactivity disorder school difficulties methylphenidate |
Additional relevant MeSH terms:
|
Neurofibromatosis 1 Osteitis Fibrosa Cystica Neurofibromatoses Neurofibroma Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Nervous System Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |
Genetic Diseases, Inborn Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Methylphenidate Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013