Tics associated with Tourette’s Disorder in children and adolescents MedDRA version: 14.1 Level: PT Classification code 10044126 Term: Tourette's disorder System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained from a legally acceptable representative (eg, guardian or caregiver), in accordance with requirements of the trial center’s IRB/IEC, prior to the initiation of any protocol-required procedures. In addition, the subject, as required by the trial center’s IRB/IEC, must provide informed assent at Baseline and as such must be able to understand that he or she can withdraw from the trial at any time. 2. The subject and the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator. 3. The subject completed Trial 31-12-293. Subjects who completed the Week 8 visit of Trial 31-12-293 are defined as trial completers. Are the trial subjects under 18? yes Number of subjects for this age range: 96 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject experienced AEs during the double-blind trial that would, in the investigator's judgment, preclude further exposure to aripiprazole. 2. The subject had protocol violations during the double-blind trial considered major in the judgment of the investigator (significant noncompliance, use of prohibited concomitant medications, concern with use of drugs of abuse, etc.), which would deem them poor candidates for this trial. 3. A positive drug screen at Baseline (ie, Day 0/last visit of double-blind trial, Protocol 31-12-293) for cocaine, alcohol, or other drugs of abuse (excluding caffeine, nicotine, or prescribed psychostimulants for ADD/ADHD) which will result in early termination on Week 1. 4. Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 days following the last dose of study drug, or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 30 days following the last dose of study drug. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom, or sponge with spermicide. 5. Females who have a positive urine pregnancy test result prior to receiving trial drug, or are pregnant or lactating. 6. The subject represents a significant risk of committing suicide based on a routine psychiatric status examination, investigator’s judgment or who have an answer of “yes” on any question other than 1-3 on the C-SSRS. 7. Body weight is lower than 16 kg. 8. The following vital signs and ECG results are exclusionary: 1) Diastolic blood pressure > 105 mmHg 2) QTc = 450 msec on either the QTcB (Bazett’s) or QTcF (Fridericia) corrections on 2 of 3 time points (see NOTE below) The following laboratory test results will result in discontinuation at the Week 1 visit: 1) Platelets = 75,000/mm3 2) Hemoglobin = 9 g/dL 3) Neutrophils, absolute = 1000/mm3 4) Aspartate aminotransferase (AST) > 3 x ULN as defined by the central laboratory 5) Alanine aminotransferase (ALT) > 3 x ULN as defined by the central laboratory 6) Creatinine = 2 mg/dL NOTE: In addition, subjects should be excluded (or discontinued at the Week 1 visit for abnormal laboratory tests) if they have any other vital sign results or ECG findings which in the investigator’s judgment are medically significant and would impact the safety of the subject or the interpretation of the trial results. Criteria are provided in the protocol to assist investigators in their assessments of results that may be potentially medically significant, depending on the subject’s medical history and clinical presentation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of aripiprazole once-daily treatment with oral tablets in children and adolescents (7 -17 years of age) with a diagnosis of Tourette’s Disorder;Secondary Objective: To evaluate the efficacy of once-daily aripiprazole in the suppression of tics in children and adolescents with a diagnosis of Tourette’s Disorder, as measured by change from Baseline to endpoint on the TTS of the YGTSS;Primary end point(s): Safety, including the following: • AEs • Laboratory tests (haematology, serum chemistry [including prolactin and thyroid stimulating hormone (TSH)], urinalysis, and pregnancy tests) • Vital signs • ECGs • AIMS and other EPS scales • C-SSRS • ADD/ADHD Subscale of SNAP-IV • CY-BOCS • CDRS-R • PARS • Body weight • Waist circumference • Body mass index (BMI);Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from Baseline to endpoint in YGTSS TTS • Mean CGI-TS change score at endpoint (change score obtained from CGI-TS improvement scale assessment) • Change from Baseline to endpoint in CGI-TS severity score • Mean change from Baseline to endpoint in Total YGTSS score • Response rates (clinical response will be defined as > 25% improvement from Baseline to endpoint in YGTSS TTS OR a CGI-TS change score of 1 [very much improved] or 2 [much improved] at endpoint) • Treatment discontinuation rates;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Argentina, Belgium, Bulgaria, Canada, Finland, Germany, Hungary, Italy, Mexico, Netherlands, Peru, Poland, Romania, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactEva Kohegyi
Otsuka Pharmaceutical Development & Commercialization, Inc.
Outcome results
None listed