Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT ID: NCT01727700

Last Updated: 2015-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-09-30

Brief 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.

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.

Conditions

Tourette's Disorder; Tic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Matching Placebo Once-Daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Aripiprazole 5 mg or 10 mg

Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Once-daily, tablet

Aripiprazole 10 mg or 20 mg

Aripiprazole 10 mg 20 mg Immediate Release Once-Daily

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Once-daily, tablet

Interventions

Aripiprazole

Once-daily, tablet

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Abilify

Eligibility 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 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

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

Mount 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

Cleveland, Ohio, United States

Middleburg Heights, Ohio, United States

Oklahoma City, Oklahoma, United States

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

Kentville, Nova Scotia, Canada

Parry Sound, Ontario, Canada

Toronto, Ontario, Canada

Whitby, Ontario, Canada

Dresden, Germany, Germany

Freiburg im Breisgau, Germany, Germany

Mannheim, Germany, Germany

Würzburg, Germany, Germany

Budapest, Hungary, Hungary

Szeged, Hungary, Hungary

Catania, Italy, Italy

Milan, Italy, Italy

Roma, Italy, Italy

Mexico City, Mexico City, Mexico

Durango, Mexico, Mexico

Leon, Mexico, Mexico

Bucharest, Romania, Romania

Iași, Romania, Romania

Madrid, Spain, Spain

Gothenburg, Sweden, Sweden

Countries

United States; Canada; Germany; Hungary; Italy; Mexico; Romania; Spain; Sweden

References

Sallee F, Kohegyi E, Zhao J, McQuade R, Cox K, Sanchez R, van Beek A, Nyilas M, Carson W, Kurlan R. Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):771-781. doi: 10.1089/cap.2016.0026. Epub 2017 Jul 7.

Reference Type: DERIVED

PMID: 28686474 (View on PubMed)

Other Identifiers

31-12-293

Identifier Type: -

Identifier Source: org_study_id