Tourette’s Disorder 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. The subject successfully completed participation in either double-blind Trial 31-10-272 or Trial 31-10-273. In both instances, the subject must complete all required assessments for the Week 8/Early Termination Visit to be eligible for rollover in to this open-label trial. 2. 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. 3. 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. Are the trial subjects under 18? yes Number of subjects for this age range: 156 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 31-10-272 or 31-10-273) 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) > 3x upper limit of normal as defined by the central laboratory 5) Alanine aminotransferase (ALT) > 3x upper limit of normal 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 Appendix 5 to assist investigators in their assessments of results that may be potentially medically significant, depending on the subject’s medical history and clinical presentation. Abnormal results for laboratory parameters or vital signs should be repeated to ensure reproducibility of the abnormality before excluding a subject based on the criteria noted above. Based on the QTcB or QTcF corrections reported by the central service, a subject will be excluded if either of the corrections exceed 450 msec for 2 or more of the 3 time points of the ECGs conducted. If only 1 ECG time point has a corrected QTc greater than 450 msec on either correction fac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are the following: • To evaluate the efficacy of Once-weekly 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. • To evaluate the long-term effect of Once-weekly aripiprazole on health-related quality of life in children and adolescents with a diagnosis of Tourette’s Disorder, as measured by the Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL).;Main Objective: The primary objective of the trial is to evaluate the long-term safety and tolerability of aripiprazole Once-weekly treatment with oral tablets in children and adolescents (7 to 17 years) with a diagnosis of Tourette’s Disorder.;Primary end point(s): The primary endpoint of this trial is safety, including the following: • AEs • Laboratory tests (hematology, serum chemistry [including prolactin and thyroidstimulating 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 plus a 30 day follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints will be the following: • Change from Baseline to endpoint in YGTSS TTS. • Mean CGI-TS change score at endpoint (change score obtained from CGI-TS improvement scale assessment) • 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 The functional outcome endpoint (considered a secondary endpoint) will be the mean changes from Baseline to endpoint in GTS-QOL overall score.;Timepoint(s) of evaluation of this end point: 52 weeks plus a 30 day follow-up | — |
Countries
Bulgaria, Canada, Germany, Hungary, India, Korea, Republic of, Romania, Taiwan, Ukraine, United States
Contacts
Public ContactDorota Plewicka, MD
Covance
Outcome results
None listed