Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Completed · Phase 3

Conditions studied: Tourette's Disorder, Tic Disorder

In brief

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.

Key facts

Study ID

NCT01727713

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

110

Starts

2013-01-01

Expected to finish

2014-09-01

Last updated by the study team

2015-10-16

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Dothan, Alabama, United States
• Study site — Goodyear, Arizona, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — Wildomar, California, United States
• Study site — Norwich, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Waldorf, Maryland, United States
• Study site — Bloomfield Hills, Michigan, United States
• Study site — Mount Arlington, New Jersey, United States
• Study site — Summit, New Jersey, United States
• Study site — Manhasset, New York, United States
• Study site — Rochester, New York, United States
• Study site — Avon Lake, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Orem, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Norfolk, Virginia, United States
• Study site — Petersburg, Virginia, United States

Full record on ClinicalTrials.gov

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