Status:
COMPLETED
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Tourette's Disorder
Eligibility:
All Genders
7-18 years
Phase:
PHASE3
Brief Summary
The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
Eligibility Criteria
Inclusion
- The participants successfully completed the final assessment visit in either Study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352). The participants completed all required assessments for the Week 8/Early Termination Visit to be eligible for rollover in to this open-label trial.
- Written informed consent form (ICF) obtained from a legally acceptable representative \& informed assent at Baseline as applicable by trial center's Institutional review board/independent ethics committee (IRB/IEC).
- The participant, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.
Exclusion
- The participants experienced adverse events (AEs) during the double-blind study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
- The participants had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the participant a poor candidate for the trial.
- A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which will result in early termination at Week 1.
- Sexually active patients who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 and 30 days following the last dose of study drug for male and female respectively.
- Participants representing Risk of committing suicide.
- Body weight lower than 16 kg.
- Abnormal laboratory test results (Platelet, Hemoglobin, Neutrophils, Aspartate aminotransferase, Alanine aminotransferase, Creatinine) vital signs and Electrocardiogram (ECG) results.
Key Trial Info
Start Date :
October 19 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2014
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01416441
Start Date
October 19 2011
End Date
March 13 2014
Last Update
October 7 2021
Active Locations (80)
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Dothan, Alabama, United States, 36303
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Little Rock, Arkansas, United States, 72205
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Los Angeles, California, United States, 90095
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Sacramento, California, United States, 95815