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 Information
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
Administrative Informations
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