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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00169611 |
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Date of registration:
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09/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate
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Scientific title:
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Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00169611 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Laurence LION-FRANCOIS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Service de Neuropédiatrie - Hôpital Femme Mère Enfant - Hospices Civils de Lyon - 59 bd Pinel - 69677 BRON - France |
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Name:
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Isabelle KEMLIN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Service de Neuropédiatrie - Hôpital Armand Trousseau - PARIS - France |
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Key inclusion & exclusion criteria
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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
Age minimum:
7 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neurofibromatosis Type 1
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Intervention(s)
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Drug: methylphenidate
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Primary Outcome(s)
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Effect of methylphenidate compared to placebo on ADHD. Time of measurements are realised on day 0, day 28, day 63 + 2 days.
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Secondary Outcome(s)
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Time of measurements are realised on day 0, day 28, day 63 + 2 days.
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To evaluate the efficacy of methylphenidate compared to placebo on specific neuropsychologic, depression and anxiety scales
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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).
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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