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Study Evaluating the Safety and Efficacy of Fixed-dose 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); Placebo (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 efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Clinical Details

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).

Secondary outcome:

Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.

Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score

Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score

Response Rate

Treatment Discontinuation Rate

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 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 has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. 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: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- male or female, 7 to 17 year old (inclusive) at the time of signing consent

- meets DSM-IV-TR diagnostic criteria for Tourette's Disorder

- Presenting tic symptoms cause impairment in the subject's normal routines, which

include academic achievement, occupational functioning, social activities, and/or relationships

- Females of childbearing potential must have a negative pregnancy test, must be

practicing acceptable double-barrier methods of contraception and must not be pregnant or lactating

- Written informed consent obtained from a legally acceptable representative & informed

assent at Screening 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:

- Clinical presentation and/or history, consistent with another neurologic condition

that may have accompanying abnormal movements

- History of schizophrenia, bipolar disorder, or other psychotic disorder

- Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed

and/or had exacerbations of tic disorder after initiation of stimulant treatment

- Currently meets DSM-IV-TR criteria for a primary mood disorder

- Severe Obsessive Compulsive Disorder (OCD)

- Taken aripiprazole within 30 days of the Screening visit

- Received any investigational agent in a clinical trial within 30 days prior to

Screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomized into a clinical trial with Once-daily aripiprazole at any time

- History of neuroleptic malignant syndrome

- 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

- Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization

- Requiring cognitive behavioral therapy (CBT) for Tourette's during trial

- Subject meets DSM-IV-TR criteria for any significant psychoactive substance use

disorder within the past 3 months

- Positive drug screen

- Subject requires medications not allowed per protocol

- Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing

and for duration of trial

- Use of herbal medications of any kind and nutritional or dietary supplements for

Tourette's disorder within 7 days prior to dosing and for the duration of the trial

- Inability to swallow tablets or tolerate oral medication

- Abnormal laboratory test results, vital signs and ECG results

Locations and Contacts

Dresden, Germany

Freiburg, Germany

Mannheim, Germany

Wurzburg, Germany

Budapest, Hungary

Szeged, Hungary

Catania, Italy

Milano, Italy

Roma, Italy

Durango, Mexico

Leon, Mexico

Mexico City, Mexico

Bucharest, Romania

Iasi, Romania

Madrid, Spain

Goteborg, Sweden

Dothan, Alabama, United States

Goodyear, Arizona, United States

Tucson, Arizona, United States

Corona, California, United States

Sacramento, California, United States

San Diego, California, United States

Santa Ana, California, United States

Wildomar, California, United States

Norwich, Connecticut, United States

Bradenton, Florida, United States

Gainsville, Florida, United States

Leesburg, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

Orange City, Florida, United States

Orlando, Florida, United States

St Petersburg, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Columbus, Georgia, United States

Savannah, Georgia, United States

Naperville, Illinois, United States

Indianapolis, Indiana, United States

Overland Park, Kansas, United States

Wichita, Kansas, United States

Louisville, Kentucky, United States

Waldorf, Maryland, United States

Bloomfield Hills, Michigan, United States

Mt Arlington, New Jersey, United States

Summit, New Jersey, United States

Albuquerque, New Mexico, United States

Manhasset, New York, United States

New York, New York, United States

Rochester, New York, United States

Staten Island, New York, United States

Durham, North Carolina, United States

Kentville, Nova Scotia, Canada

Cleveland, Ohio, United States

Middleburg Heights, Ohio, United States

Oklahoma City, Oklahoma, United States

Parry Sound, Ontario, Canada

Toronto, Ontario, Canada

Whitby, Ontario, Canada

Eugene, Oregon, United States

Philadelphia, Pennsylvania, United States

Mt. Pleasant, South Carolina, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Orem, Utah, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Henrico, Virginia, United States

Norfolk, Virginia, United States

Bellevue, Washington, United States

Bothell, Washington, United States

Middleton, Wisconsin, United States

Additional Information

Starting date: November 2012
Last updated: February 12, 2015

Page last updated: August 20, 2015

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