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Sponsored by: |
New York University School of Medicine |
Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00241176 |
The purpose of this study is to determine if Abilify will reduce tics (repetitive, uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with Tourette’s Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable movements or vocalizations).
Condition | Intervention | Phase |
Tourette's Syndrome Tic Disorders |
Drug: Aripiprazole |
Phase IV |
Genetics Home Reference related topics: | familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome |
MedlinePlus related topics: | Tourette Syndrome |
ChemIDplus related topics: | Aripiprazole |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder |
Estimated Enrollment: | 12 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | August 2007 |
The aims of this study are to obtain systematic data regarding dosing and safety of aripiprazole (Abilify) in the treatment of youth with Tourette’s Disorder (TD). Tourette’s Disorder is characterized by multiple motor (more than one uncontrollable movement) and vocal tics (vocal outbursts) which have been present for more than 1 year, with onset before the age of 18. The disorder causes marked distress in social, occupational or other important areas of functioning. Abilify has been approved by the United States Food and Drug Administration (FDA) to treat adults with schizophrenia but has not been approved to treat Tourette’s Disorder (TD) so it is considered experimental or investigational in this study.
Ages Eligible for Study: | 7 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Natalie Wieland, M.A. | 212-263-8672 | natalie.wieland@med.nyu.edu |
Contact: Matthew Schrock | 212-263-8992 | matthew.schrock@med.nyu.edu |
United States, New York | |||||
NYU Child Study Center | Recruiting | ||||
New York, New York, United States, 10016 | |||||
Contact: Natalie Wieland, M.A. 212-263-8672 natalie.wieland@med.nyu.edu | |||||
Contact: Matthew Schrock 212-263-8992 matthew.schrock@med.nyu.edu | |||||
Principal Investigator: Barbara J Coffey, M.D., M.S. |
New York University School of Medicine |
Principal Investigator: | Barbara J Coffey, M.D, M.S. | NYU School of Medicine, NYU Child Study Center |
NYU Child Study Center website 
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Study ID Numbers: | H12189 |
First Received: | October 14, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00241176 |
Health Authority: | United States: Institutional Review Board |
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