Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169611
Status:
COMPLETED
Last Update Posted:
2011-01-27
First Post:
2005-09-09
Brief Title:
NF1-Attention Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate A Double-blind Randomised Study Methylphenidate Versus Placebo
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neurofibromatosis type 1 NF1 is an autosomal dominant disorder with an estimated prevalence of 12190 to 16711 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None