Tics associated with Tourette Syndrome(TS)
Conditions
Interventions
Product Code: TEV-50717
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Deutetrabenazine
CAS Number: 1392826-25 3
Current S
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient is 6 to 16 years of age, inclusive, at baseline. b. Patient weighs at least 44 pounds (20 kg) at baseline. c. Patient meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria for TS and, in the opinion of the investigator, patient, and caregiver/adult, the patient's active tics are causing distress or impairment. d. Patient has a TTS of 20 or higher on the YGTSS at screening and baseline. e. Patient is able to swallow study medication whole. f. Patient and caregiver/adult are willing to adhere to the medication regimen and to comply with all study procedures. g. Patient is in good general health, as indicated by medical and psychiatric history as well as physical and neurological examination. h. In the investigator's opinion, the patient and caregiver/adult have the ability to understand the nature of the study and its procedures, and the patient is expected to complete the study as designed. i. Patient and caregiver/adult provided written informed consent according to local regulations (eg, the patient has provided written assent and/or co-consent for patients 14 years of age and older, as appropriate). j. Females of childbearing potential may be included only if they have a negative ß-human chorionic gonadotropin test at baseline or are sterile. Definitions of sterile given in Appendix L. k. Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) or female partners of male participants must use highly effective birth control methods for the duration of the study (ie, starting at screening) and for 30 days or 5 half-lives, whichever is longer after last dose of IMP. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: a. Patient has a neurologic disorder other than TS that could obscure the evaluation of tics. b. The patient's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with Autism Spectrum Disorder. c. Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder. d. Patient has clinically significant depression at screening or baseline. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening. e. Patient has a history of suicidal intent or related behaviors within 2 years of screening: -Previous intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought - Previous suicidal preparatory acts or behavior f. Patient has a history of a previous actual, interrupted, or aborted suicide attempt. g. Patient has a first-degree relative who has completed suicide. h. Patient has clinically significant OCD at baseline that, in the opinion of the investigator, is the primary cause of impairment. i. Patient has received CBIT for TS or CBT for OCD within 4 weeks of screening. j. Patient has received any of the following concomitant medications for tics within the specified exclusionary windows of screening: -Within 3 months: depot neuroleptics, botulinum toxin, or tetrabenazine -Within 21 days: reserpine -Within 14 days: neuroleptics (oral), typical and atypical antipsychotics, metoclopramide, levodopa, and dopamine agonists Note: Use of benzodiazepines is allowed if primary use is not for tics and dosing has been stable for at least 4 weeks before screening. Note: Use of topiramate (up to 200 mg/day) is allowed if dosing has been stable for at least 4 weeks before screening. Note: Use of guanfacine or clonidine is allowed if dosing has been stable for at least 4 weeks before screening. k. Patient has received treatment with deep brain stimulation, or transmagnetic stimulation or transcranial direct current stimulation for reduction of tics within 4 weeks of the screening visit. l. Patient has an unstable or serious medical illness at screening or baseline m. Patient has a QT interval corrected for heart rate using Frederica's formula (QTcF) interval value >450 msec (males) or >460 msec (females) or >480msec (with right bundle branch block) on 12-lead ECG at screening, OR requires treatment with drugs known to prolong the QT interval n. Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure. o. Patient has evidence of hepatic impairment, as indicated by: -Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 × the upper limit of the normal range (ULN) at screening - Alkaline phosphatase (ALP) or total bilirubin (Tbil) >2 × ULN at screening Note: Patients with Gilbert's Syndrome are eligible to participate if approved by the medical monitor. Note: Patients with abn
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in the Tourette Syndrome-Clinical Global Impression (TS-CGI) score from baseline to week 12 2. Change in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) score from baseline to week 12 3. Change in the Child and Adolescent Gilles de la Tourette Syndrome – Quality of Life (C&A-GTS-QOL) activities of daily living (ADL) subscale score from baseline to week 12 ;Timepoint(s) of evaluation of this end point: From baseline to Week 12 | — |
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective of the study is to evaluate the safety and tolerability of titration and maintenance therapy with TEV-50717.;Primary end point(s): Change in the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) from baseline to week 12;Timepoint(s) of evaluation of this end point: From baseline to Week 12;Main Objective: The primary objective of this study is to evaluate the efficacy of TEV 50717 to reduce motor and phonic tics associated with TS. | — |
Countries
Bulgaria, Canada, Denmark, Germany, Russian Federation, Serbia, Spain, United States
Contacts
Public ContactDr Betsy Garofalo
Nuvelution TS Pharma, Inc
Outcome results
None listed