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

NCT ID: NCT01727713

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-09-30

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.

Conditions

Tourette's Disorder; Tic Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole

Aripiprazole Immediate Release Once-Daily

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Open Label: Once-Daily formulation of aripiprazole flex dose regimine

Interventions

Aripiprazole

Open Label: Once-Daily formulation of aripiprazole flex dose regimine

Intervention Type: DRUG

Other Intervention Names

Abilify

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Kohegyi, MD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

Dothan, Alabama, United States

Goodyear, Arizona, United States

Orange, California, United States

Sacramento, California, United States

Wildomar, California, United States

Norwich, Connecticut, United States

Bradenton, Florida, United States

Orange City, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Waldorf, Maryland, United States

Bloomfield Hills, Michigan, United States

Mount Arlington, New Jersey, United States

Summit, New Jersey, United States

Manhasset, New York, United States

Rochester, New York, United States

Avon Lake, Ohio, United States

Cleveland, Ohio, United States

Houston, Texas, United States

San Antonio, Texas, United States

Orem, Utah, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Petersburg, Virginia, United States

Bellevue, Washington, United States

Toronto, Ontario, Canada

Whitby, Ontario, Canada

Nova Scotia, , Canada

Budapest, , Hungary

Szeged, , Hungary

Catania, , Italy

Milan, , Italy

Countries

United States; Canada; Hungary; Italy

Other Identifiers

31-12-294

Identifier Type: -

Identifier Source: org_study_id