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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole

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