Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder

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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