Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT ID: NCT01418339

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-27
• Study Completion Date: 2013-11-06

Brief Summary

The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.

Conditions

Tourette's Disorder

Study Design

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

Study Groups

Aripiprazole

Aripiprazole was administered orally once a week (QW) for 8 weeks in a double-blind manner. Participants randomized to aripiprazole received aripiprazole tablets at a starting dose of 52.5 milligrams (mg) QW on Day 0. At Week 1, according to the investigator's discretion based on efficacy and tolerability, the dose of aripiprazole could remain at 52.5 mg QW or could be increased to 77.5 mg QW. The dose could be increased to 110 mg QW as early as Week 2. For the remainder of the study (up to Week 8), the dose was to be adjusted up and down among these three dose levels, as determined by the investigator.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Aripiprazole tablet administered orally once a week.

Placebo

Participants randomized to placebo received aripiprazole-matching placebo, tablet, orally, QW for 8 weeks in a double-blind manner.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Aripiprazole-matching placebo tablet administered orally once a week.

Interventions

Aripiprazole

Aripiprazole tablet administered orally once a week.

Intervention Type: DRUG

Placebo

Aripiprazole-matching placebo tablet administered orally once a week.

Intervention Type: DRUG

Other Intervention Names

ABILIFY

Eligibility Criteria

Inclusion Criteria

• 7 to 17 year old with diagnostic and statistical manual of mental disorders, fourth edition -text revision (DSM-IV-TR) diagnostic criteria for Tourette's disorder (TD), confirmed by the kiddie schedule for affective disorders and schizophrenia - present and lifetime version (K-SADS-PL), including the Diagnostic Supplement 5
• Has a total tic score (TTS) ≥20 on the yale global tic severity scale (YGTSS) at Screening and Baseline
• Presenting tic symptoms cause impairment in the participant'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 form (ICF) obtained from a legally acceptable representative & informed assent at Screening as applicable by study center's Institutional review board/independent ethics committee (IRB/IEC)
• The participant, 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.
• Participant receiving psychostimulants for treatment of attention-deficit disorder/Attention-deficit hyperactivity disorder (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), per children's yale-brown obsessive compulsive scale (CY-BOCS) score >16.
• Taken aripiprazole within 30 days of the Screening visit.
• Received any investigational agent in a clinical trial within 30 days prior to Screening or who were randomized into a clinical trial with Once-weekly aripiprazole at any time.
• History of neuroleptic malignant syndrome.
• Sexually active participants not using 2 approved methods of contraception; breastfeeding or pregnant.
• Risk of committing suicide
• Bodyweight lower than 16 kg
• Taken neuroleptic or antiparkinson drugs <14 days prior to randomization.
• Requiring cognitive-behavioral therapy (CBT) for TD during study.
• Participant meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months.
• Positive drug screen
• Participant 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 study.
• Inability to swallow tablets or tolerate oral medication
• Abnormal laboratory test results, vital signs and Electrocardiogram (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

Little Rock, Arkansas, United States

Sacramento, California, United States

Santa Ana, California, United States

Wildomar, California, United States

Hialeah, Florida, United States

Orange City, Florida, United States

St. Petersburg, Florida, United States

Overland Park, Kansas, United States

New Orleans, Louisiana, United States

Bloomfield Hills, Michigan, United States

Staten Island, New York, United States

Avon Lake, Ohio, United States

Cleveland, Ohio, United States

Middleburg Heights, Ohio, United States

Philadelphia, Pennsylvania, United States

Dallas, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Bothell, Washington, United States

Kelowna, British Columbia, Canada

Toronto, Ontario, Canada

Whitby, Ontario, Canada

Budapest, , Hungary

Szeged, , Hungary

León, Guanajuato, Mexico

Monterrey, Nuevo León, Mexico

Durango, , Mexico

Gyeonggi-do, , South Korea

Gyeongsang, , South Korea

Incheon, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Changhua, , Taiwan

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Countries

United States; Canada; Hungary; Mexico; South Korea; Taiwan

Other Identifiers

2011-000467-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

31-10-272

Identifier Type: -

Identifier Source: org_study_id