Brief Title
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Official Title
An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation
Secondary Outcome
Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score
Condition
Tourette's Disorder
Intervention
Aripiprazole
Study Arms / Comparison Groups
Aripiprazole
Description: Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
170
Start Date
October 19, 2011
Completion Date
March 13, 2014
Primary Completion Date
March 13, 2014
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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.
Gender
All
Ages
7 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
Eva Kohegyi, MD, ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT01416441
Organization ID
31-10-274
Secondary IDs
2011-000469-11
Responsible Party
Sponsor
Study Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor
Eva Kohegyi, MD, Study Director, Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date
September 2021