DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tourette's Disorder; Tic Disorder

Intervention: Aripiprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Official(s) and/or principal investigator(s):
Eva Kohegyi, MD, Study Director, Affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number and percentage of subjects with adverse events

Number and percentage of subjects with clinically significant abnormal laboratory test results, vitals, and ECGs

Secondary outcome:

Change from Baseline to endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale(YGTSS)

The long-term effect of Once-daily aripiprazole measured by the Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL)

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.

Eligibility

Minimum age: 7 Years. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

Nova Scotia, Canada

Budapest, Hungary

Szeged, Hungary

Catania, Italy

Milano, Italy

Dothan, Alabama, United States

Goodyear, Arizona, United States

Orange City, 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

Mt 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

Toronto, Ontario, Canada

Whitby, Ontario, Canada

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

Additional Information

Starting date: January 2013
Last updated: December 3, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017