Brief Title
Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
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
Brief 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.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage of Participants With Adverse Events.
Secondary Outcome
Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
Condition
Tourette's Disorder
Intervention
Aripiprazole
Study Arms / Comparison Groups
Aripiprazole
Description: Aripiprazole Immediate Release Once-Daily
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
110
Start Date
January 2013
Completion Date
September 2014
Primary Completion Date
August 2014
Eligibility 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
Gender
All
Ages
7 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
Eva Kohegyi, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01727713
Organization ID
31-12-294
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 2015