Status:
COMPLETED
Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Tourette's Disorder
Eligibility:
All Genders
7-17 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2014
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01418352
Start Date
August 2 2011
End Date
March 12 2014
Last Update
October 7 2021
Active Locations (35)
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1
Dothan, Alabama, United States, 36303
2
San Francisco, California, United States, 94143
3
Gainesville, Florida, United States, 32610
4
Miami, Florida, United States, 33126