Dyskinesia in cerebral palsy (DCP) MedDRA version: 20.1 Level: LLT Classification code 10068804 Term: Athetoid cerebral palsy System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Austedo
Product Name: TEV-50717 (deutetrabenazine)
Product Code: TEV-50717
Pharmaceutical Form: Film-coated tablet
INN or Pr
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have completed Study TV50717-CNS-30080 have already met the criteria below: 1. Patient is of an eligible age from parent Study TV50717-CNS-30080. 2. Patient weighs at least 12 kg (26 lb) on day 1 of this study. 3. Patient is able to swallow TEV-50717 tablet whole. 4. Patient and caregiver/adult are willing to adhere to TEV-50717 regimen and comply with all study procedures. 5. Patient is in good general health, as indicated by medical and psychiatric history and physical and neurological examination. 6. 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. 7. Patient and caregiver/adult provide written informed consent/assent, depending on the child’s age, as appropriate, according to local regulations. 8. Females who are postmenarchal or =12 years of age may be included only if they have a negative ß-HCG test on day 1 or are sterile. 9. Females who are postmenarchal or =12 years of age whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study (ie, starting at day 1) and for 30 days after last dose of TEV-50717. Are the trial subjects under 18? yes Number of subjects for this age range: 185 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: Patients will not be randomized/enrolled in this study if they meet any of the following criteria: 1. Patient has a predominant movement disorder other than dyskinesia. 2. Patient’s predominant motor symptoms are dystonic. 3. Patient’s predominant motor symptoms are spastic. 4. Patient has another movement disorder that could impair the motor assessment in the MD-CRS part II. 5. Patient has clinically significant depression at day 1 of this study. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose. 6. Patient has a history of suicidal intent or related behaviors: (a) previous intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought; (b) previous suicidal preparatory acts or behaviour. 7. Patient has a history of a previous actual, interrupted, or aborted suicide attempt. 8. Patient has a first-degree relative who has completed suicide. 9. Patient who is currently receiving or who has received botulinum neurotoxin (BoNT) in an investigational clinical trial. Note: Patients may be included in the study if they have at least 2 treatments of Food and Drug Administration-approved BoNT at a regular interval (eg, every 3 to 4 months), in reasonably stable dosages and locations (subject to investigator’s judgement) to treat lower limb spasticity or dystonia. 10. Patient has received any of the following concomitant medications for dystonia or chorea within the specified exclusionary windows of day 1 of this study: (a) within 3 months: depot neuroleptics; (b) within 30 days: tetrabenazine or valbenazine; (c) within 21 days: reserpine; (d) within 14 days: neuroleptics (oral), typical and atypical antipsychotics, metoclopramide, levodopa, dopamine agonists, and monoamine oxidase inhibitors. 11. Patient has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP, or the patient is not in a stable clinical condition. 12. Patient has recent surgical procedure or is anticipated to have a surgical procedure during the study that, in the opinion of the investigator, makes the patient unsuitable for the study. 13. Patient has a severe mental disability or an unstable or serious medical illness (eg, epilepsy) that, in the opinion of the investigator, could jeopardize or would compromise the patient’s ability to participate in this study. 14. Patient has a QT interval (QTc) corrected for heart rate using Fridericia’s formula (QTcF) value >450 msec on 12-lead ECG at day 1 of this study. 15. Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure. 16. Patient has evidence of hepatic impairment, as indicated by the following: (a) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5× the upper limit of the normal range (ULN) at day 1 of this study; (b) alkaline phosphatase (ALP) or total bilirubin (Tbil) >2×ULN at day 1 of this study. Note: Patients with Gilbert’s syndrome are eligible to participate if approved by the medical monitor. Note: Patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety and tolerability of long-term therapy with TEV-50717 in children and adolescents with DCP.;Secondary Objective: The secondary objective of this study is to evaluate the efficacy of long-term therapy with TEV-50717 in reducing the severity of DCP.; Primary end point(s): Safety measures/endpoints: - Incidence of adverse events - Observed values and changes in vital signs from day 1 to each visit in which vital signs are assessed - Observed values and changes in children’s C-SSRS (Columbia-Suicide Severity Rating Scale) from day 1 to each visit in which the scale is administered - Observed values in electrocardiogram (ECG) parameters and shifts for clinically significant abnormal findings from day 1 to each visit in which the ECG test is performed - Observed values and changes in clinical laboratory parameters (hematology, serum chemistry and urinalysis) from day 1 to each visit in which the laboratory parameters are assessed - Observed values and changes in ESSRS (Extrapyramidal Symptom Rating Scale - subscales I and II) from day 1 to each visit in which the scale is administered - Observed values and changes in CBCL (Child Behavior Checklist) from day 1 to each visit in which the scale is administered - Observed values and changes in ESS (Epworth Sleepiness Scale) from day 1 to each visit in which the scale is administered. ;Timepoint(s) of evaluation of this end point: Day 1 to each visit the assessments are performed/scale is administered until W55 (End of Study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy measures/endpoints: - Change in the total score of MD-CRS (Movement Disorder-Childhood Rating Scale) part I from day 1 to each visit in which the scale is administered - Change in the total score of MD-CRS (Movement Disorder-Childhood Rating Scale) part II from day 1 to each visit in which the scale is administered - Change in the MD-CRS Global Index (calculated from MD-CRS part I and II total scores) from day 1 to each visit in which MD-CRS part I and II are administered - Change in the Ca-GI-I (Caregiver Global Impression of Improvement) score from week 14 to each visit in which the scale is administered - Change in the CGI-I (Clinical Global Impression of Improvement) score from week 1 to each visit in which the scale is administered - Change in the CGI-S (Clinical Global Impression of Severity) score from day 1 to each visit in which the scale is administered - Change in the PEDI-CAT (Pediatric Evaluation Disability Inventory-Computer Adapted Test) score from day 1 to each visit in which the scale is administered - Change in the UHDRS-TMS (Unified Huntington’s Disease Rating Scale-Total Motor Score) score from day 1 to each visit in which the scale is administered - Change in the COPM (Canadian Occupational Performance Measure) score from day 1 to each visit in which the scale is administered ;Timepoint(s) of evaluation of this end point: Day 1/week 1/week 14 to each visit the scale is administered until W53-54-55 (depending on the scale). | — |
Countries
Belgium, Canada, Denmark, Israel, Italy, Poland, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Manager
Teva Branded Pharmaceutical Products R&D, Inc.
Outcome results
None listed