Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
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
2 other identifiers
interventional
135
6 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2011
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2011
CompletedFirst Submitted
Initial submission to the registry
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2013
CompletedResults Posted
Study results publicly available
October 7, 2021
CompletedOctober 7, 2021
September 1, 2021
2.3 years
August 1, 2011
September 7, 2021
September 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)
The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The TTS ranged from 0 (none) to 50 (severe) with a higher score represent more severe symptoms (greater reduction from baseline for greater improvement). Mixed Effect Repeated Measure Model (MMRM) analysis was performed.
Baseline to Week 8
Secondary Outcomes (2)
Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score
Baseline to Week 8
Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score
Baseline to Week 8
Study Arms (2)
Aripiprazole
EXPERIMENTALAripiprazole 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.
Placebo
PLACEBO COMPARATORParticipants randomized to placebo received aripiprazole-matching placebo, tablet, orally, QW for 8 weeks in a double-blind manner.
Interventions
Aripiprazole tablet administered orally once a week.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Sacramento, California, 95815, United States
Unknown Facility
Santa Ana, California, 92701, United States
Unknown Facility
Wildomar, California, 92595, United States
Unknown Facility
Hialeah, Florida, 33012, United States
Unknown Facility
Orange City, Florida, 32763, United States
Unknown Facility
St. Petersburg, Florida, 33701, United States
Unknown Facility
Overland Park, Kansas, 66211, United States
Unknown Facility
New Orleans, Louisiana, 70114, United States
Unknown Facility
Bloomfield Hills, Michigan, 48302, United States
Unknown Facility
Staten Island, New York, 10312, United States
Unknown Facility
Avon Lake, Ohio, 44012, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Middleburg Heights, Ohio, 44130, United States
Unknown Facility
Philadelphia, Pennsylvania, 19139, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
San Antonio, Texas, 78258, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Bothell, Washington, 98011, United States
Unknown Facility
Kelowna, British Columbia, V1Y 1Z9, Canada
Unknown Facility
Toronto, Ontario, M5B 1T8, Canada
Unknown Facility
Whitby, Ontario, L1N 8M7, Canada
Unknown Facility
Budapest, 1021, Hungary
Unknown Facility
Szeged, 6725, Hungary
Unknown Facility
León, Guanajuato, 37000, Mexico
Unknown Facility
Monterrey, Nuevo León, 64710, Mexico
Unknown Facility
Durango, 34000, Mexico
Unknown Facility
Gyeonggi-do, 460727, South Korea
Unknown Facility
Gyeongsang, 626-770, South Korea
Unknown Facility
Incheon, 400-711, South Korea
Unknown Facility
Seoul, 110-769, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Unknown Facility
Seoul, 143-729, South Korea
Unknown Facility
Changhua, 50006, Taiwan
Unknown Facility
Kaohsiung City, 83301, Taiwan
Unknown Facility
Taichung, 40447, Taiwan
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Taipei, 114, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Officials
- STUDY DIRECTOR
Eva Kohegyi, MD
Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2011
First Posted
August 17, 2011
Study Start
July 27, 2011
Primary Completion
November 6, 2013
Study Completion
November 6, 2013
Last Updated
October 7, 2021
Results First Posted
October 7, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/.
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.