Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
1 other identifier
interventional
83
5 countries
35
Brief Summary
The goal of the current trial 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 below P25 for phase_3
Started Aug 2011
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2011
CompletedStudy Start
First participant enrolled
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2014
CompletedResults Posted
Study results publicly available
October 7, 2021
CompletedOctober 7, 2021
September 1, 2021
2.6 years
August 1, 2011
September 7, 2021
September 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score
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 total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms (greater reduction from baseline for greater improvement).
Baseline and Week 8
Secondary Outcomes (2)
Mean Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score
Baseline and Week 8
Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score at Week 8
Baseline and Week 8
Study Arms (4)
Matching Placebo
PLACEBO COMPARATORParticipants received aripiprazole matching placebo, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.
Aripiprazole 52.5 mg
EXPERIMENTALParticipants received aripiprazole 52.5 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.
Aripiprazole 77.5 mg
EXPERIMENTALParticipants received aripiprazole 77.5 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.
Aripiprazole 110 mg
EXPERIMENTALParticipants received aripiprazole 110 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.
Interventions
Aripiprazole tablets once weekly for 8 weeks.
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 (35)
Unknown Facility
Dothan, Alabama, 36303, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Miami, Florida, 33126, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Atlanta, Georgia, 30329, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
Cincinnati, Ohio, 45229-3039, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Charlottesville, Virginia, 22903, United States
Unknown Facility
La Crosse, Wisconsin, 54601, United States
Unknown Facility
Rousse, 7004, Bulgaria
Unknown Facility
Sofia, 1431, Bulgaria
Unknown Facility
Varna, 9010, Bulgaria
Unknown Facility
Aachen, 52074, Germany
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
München, 80336, Germany
Unknown Facility
Ulm, 89075, Germany
Unknown Facility
Bucharest, 041914, Romania
Unknown Facility
Cluj-Napoca, 400660, Romania
Unknown Facility
Craiova, 200620, Romania
Unknown Facility
Iași, 700282, Romania
Unknown Facility
Donetsk, 83008, Ukraine
Unknown Facility
Kharkiv, 61068, Ukraine
Unknown Facility
Kharkiv, 61153, Ukraine
Unknown Facility
Kyiv, 01030, Ukraine
Unknown Facility
Kyiv, 03049, Ukraine
Unknown Facility
Kyiv, 04209, Ukraine
Unknown Facility
Luhansk, 91045, Ukraine
Unknown Facility
Poltava, 36006, Ukraine
Unknown Facility
Stepanovka, 73488, Ukraine
Unknown Facility
Vinnytsia, 21005, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitations of the trial such as small numbers of subjects analyzed or technical problems leading to unreliable data.
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
August 2, 2011
Primary Completion
March 12, 2014
Study Completion
March 12, 2014
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.