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

Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)

Secondary Outcome

 Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score

Condition

Tourette's Disorder

Intervention

Aripiprazole

Study Arms / Comparison Groups

 Aripiprazole

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

135

Start Date

July 27, 2011

Completion Date

November 6, 2013

Primary Completion Date

November 6, 2013

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
      

Gender

All

Ages

7 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Eva Kohegyi, MD, , 

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT01418339

Organization ID

31-10-272

Secondary IDs

2011-000467-27

Responsible Party

Sponsor

Study Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Sponsor

Eva Kohegyi, MD, Study Director, Otsuka Pharmaceutical Development & Commercialization, Inc.

Verification Date

September 2021