Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tourette's Disorder; Tic Disorder
Intervention: Aripiprazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc. Official(s) and/or principal investigator(s): Eva Kohegyi, MD, Study Director, Affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing
Total Tic Severity in children and adolescents with Tourette's Disorder.
Clinical Details
Official title: An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number and percentage of subjects with adverse eventsNumber and percentage of subjects with clinically significant abnormal laboratory test results, vitals, and ECGs
Secondary outcome: Change from Baseline to endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale(YGTSS)The long-term effect of Once-daily aripiprazole measured by the Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL)
Detailed description:
Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance
of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent,
non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of
medications approved for the treatment of Tourette's Disorder. The goal of the current trial
is to obtain additional efficacy, safety, and tolerability data in a controlled condition of
a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder.
The trial is a 52-week extension to the double-blind trial.
The Once-daily tablet formulation that will be evaluated in this trial represents a daily
dosage regimen that is intended to be administered to children and adolescents.
Eligibility
Minimum age: 7 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Completed participation in Trial 31-12-293
- Written ICF obtained from a legally acceptable representative & informed assent at
Baseline 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:
- Experienced AEs during the double-blind trial (31-12-293) that would, in the
investigator's judgment, preclude further exposure to aripiprazole.
- The subject had protocol violations during the double-blind trial considered major in
the judgment of the investigator which would deem the subject a poor candidate for
the trial
- A positive drug screen
- 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
- Abnormal laboratory test results, vital signs and ECG results
Locations and Contacts
Nova Scotia, Canada
Budapest, Hungary
Szeged, Hungary
Catania, Italy
Milano, Italy
Dothan, Alabama, United States
Goodyear, Arizona, United States
Orange City, California, United States
Sacramento, California, United States
Wildomar, California, United States
Norwich, Connecticut, United States
Bradenton, Florida, United States
Orange City, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Waldorf, Maryland, United States
Bloomfield Hills, Michigan, United States
Mt Arlington, New Jersey, United States
Summit, New Jersey, United States
Manhasset, New York, United States
Rochester, New York, United States
Avon Lake, Ohio, United States
Cleveland, Ohio, United States
Toronto, Ontario, Canada
Whitby, Ontario, Canada
Houston, Texas, United States
San Antonio, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Petersburg, Virginia, United States
Bellevue, Washington, United States
Additional Information
Starting date: January 2013
Last updated: December 3, 2014
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