NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate
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|ClinicalTrials.gov Identifier: NCT00169611|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis Type 1||Drug: methylphenidate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
- Effect of methylphenidate compared to placebo on ADHD. Time of measurements are realised on day 0, day 28, day 63 + 2 days.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169611
|Lyon, France, 69005|
|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|