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Aripiprazole in the Treatment of Tourette's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00282139
Recruitment Status : Terminated
First Posted : January 25, 2006
Last Update Posted : October 5, 2011
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE January 23, 2006
First Posted Date  ICMJE January 25, 2006
Last Update Posted Date October 5, 2011
Study Start Date  ICMJE January 2004
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2006)
Global improvement in severity of symptoms (tic behaviors)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00282139 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2006)
Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aripiprazole in the Treatment of Tourette's Syndrome
Official Title  ICMJE Aripiprazole in the Treatment of Tourette's Syndrome
Brief Summary This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
Detailed Description This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tourette's Syndrome
Intervention  ICMJE Drug: Aripiprazole
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: January 23, 2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

DSM-IV primary diagnosis of Tourette's syndrome or chronic tic disorder;

"Moderate" severity as reflected on the CGI or the YGTSS;

Normal ECG; and,

Written informed consent/assent.

Exclusion Criteria:

Female subjects of childbearing potential who are not practicing an effective method of birth control (including abstinence);

Subjects who are pregnant or nursing women;

Subjects with known seizure disorder, a history or seizures or with conditions that lower seizure threshold;

Subjects who currently meet DSM-IV criteria for: Schizophrenia, Schizoaffective Disorder, Delusional Disorder, or Psychotic Disorder Not Otherwise Specified;

Subjects with a Psychoactive Substance Abuse disorder (within the past 3 months);

Subjects with known allergy or hypersensitivity to aripiprazole;

Subjects who have any depot neuroleptic within one treatment cycle or any other changes in psychoactive medications (with the exception of antidepressants) in one month and two months for antidepressants prior to study entry for first administration of study medication;

Subjects who have clinically significant abnormalities based on physical examination, medical history, ECG, or laboratory tests; and,

Subjects on medication that pose drug interaction potential with aripiprazole such as carbamazepine, ketoconazole, paroxetine, and fluoxetine.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282139
Other Study ID Numbers  ICMJE TSARIP703 / WIRB #20031378
00040256/00042966
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Tanya K Murphy, M.D. University of Florida
PRS Account University of Florida
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP