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

Otsuka

Status and phase

Completed

Phase 3

Conditions

Tic Disorder

Tourette's Disorder

Treatments

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01727713

31-12-294

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

7 to 18 years old

Volunteers

No Healthy Volunteers

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