The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole
in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
Minimum age: 7 Years.
Maximum age: 17 Years.
Gender(s): Both.
Inclusion Criteria:
- male or female, 7 to 17 year old (inclusive) at the time of signing consent
- meets DSM-IV-TR diagnostic criteria for Tourette's Disorder
- Presenting tic symptoms cause impairment in the subject's normal routines, which
include academic achievement, occupational functioning, social activities, and/or
relationships
- Females of childbearing potential must have a negative pregnancy test, must be
practicing acceptable double-barrier methods of contraception and must not be
pregnant or lactating
- Written informed consent obtained from a legally acceptable representative & informed
assent at Screening as applicable by trial center's IRB/IEC
- The subject, designated guardian(s) or caregiver(s) are able to comprehend and
satisfactorily comply with the protocol requirements, as evaluated by the
investigator
Exclusion Criteria:
- Clinical presentation and/or history, consistent with another neurologic condition
that may have accompanying abnormal movements
- History of schizophrenia, bipolar disorder, or other psychotic disorder
- Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed
and/or had exacerbations of tic disorder after initiation of stimulant treatment
- Currently meets DSM-IV-TR criteria for a primary mood disorder
- Severe Obsessive Compulsive Disorder (OCD)
- Taken aripiprazole within 30 days of the Screening visit
- Received any investigational agent in a clinical trial within 30 days prior to
Screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were
randomized into a clinical trial with Once-daily aripiprazole at any time
- History of neuroleptic malignant syndrome
- Sexually active patients not using 2 approved methods of contraception
- Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving
trial drug)
- Risk of committing suicide
- Body weight lower than 16 kg
- Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization
- Requiring cognitive behavioral therapy (CBT) for Tourette's during trial
- Subject meets DSM-IV-TR criteria for any significant psychoactive substance use
disorder within the past 3 months
- Positive drug screen
- Subject requires medications not allowed per protocol
- Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing
and for duration of trial
- Use of herbal medications of any kind and nutritional or dietary supplements for
Tourette's disorder within 7 days prior to dosing and for the duration of the trial
- Inability to swallow tablets or tolerate oral medication
- Abnormal laboratory test results, vital signs and ECG results
Dresden, Germany
Freiburg, Germany
Mannheim, Germany
Wurzburg, Germany
Budapest, Hungary
Szeged, Hungary
Catania, Italy
Milano, Italy
Roma, Italy
Durango, Mexico
Leon, Mexico
Mexico City, Mexico
Bucharest, Romania
Iasi, Romania
Madrid, Spain
Goteborg, Sweden
Dothan, Alabama, United States
Goodyear, Arizona, United States
Tucson, Arizona, United States
Corona, California, United States
Sacramento, California, United States
San Diego, California, United States
Santa Ana, California, United States
Wildomar, California, United States
Norwich, Connecticut, United States
Bradenton, Florida, United States
Gainsville, Florida, United States
Leesburg, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
St Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Savannah, Georgia, United States
Naperville, Illinois, United States
Indianapolis, Indiana, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Waldorf, Maryland, United States
Bloomfield Hills, Michigan, United States
Mt Arlington, New Jersey, United States
Summit, New Jersey, United States
Albuquerque, New Mexico, United States
Manhasset, New York, United States
New York, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
Durham, North Carolina, United States
Kentville, Nova Scotia, Canada
Cleveland, Ohio, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Parry Sound, Ontario, Canada
Toronto, Ontario, Canada
Whitby, Ontario, Canada
Eugene, Oregon, United States
Philadelphia, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Henrico, Virginia, United States
Norfolk, Virginia, United States
Bellevue, Washington, United States
Bothell, Washington, United States
Middleton, Wisconsin, United States