A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy

Study Overview
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Brief Summary
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Study TV50717-CNS-30081 is a 55-week study in which patients who have successfully completed the parent study (Study TV50717-CNS-30080) may be eligible to enroll in this study. 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. The secondary objective of this study is to evaluate the efficacy of long-term therapy with TEV-50717 in reducing the severity of DCP.

Official Title
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An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP)

Conditions
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Cerebral Palsy, Dyskinetic

Intervention / Treatment
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* Drug: TEV-50717


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has completed parent Study TV50717-CNS-30080. Patient weighs at least 12 kg (26 lb) on day 1 of this study. Patient is able to swallow TEV-50717 whole. NOTE- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: Patient has clinically significant depression at screening or day 1 of this study. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening or day 1 (whichever comes first) and anticipated to remain stable (dose and frequency) within the study duration. Patient has a history of suicidal intent or related behaviors based on medical or psychiatric history or the C-SSRS at screening visit, if performed, or at the day 1 visit, as applicable according to the patient's age: intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought suicidal preparatory acts or behavior. Patient has a history of a previous actual, interrupted, or aborted suicide attempt. Patient has a first-degree relative who has completed suicide. Patient has received any of the following concomitant Patient has received any of the following concomitant medications within the specified exclusionary windows from screening or day 1 (whichever comes first) of this study: within 30 days: tetrabenazine or valbenazine within 21 days: reserpine within 14 days: levodopa, dopamine agonists, and monoamine oxidase inhibitors Patient has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP since the week 15 visit of Study TV50717-CNS-30080, or the patient is not in a stable clinical condition. Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure. Patient has a known allergy to any of the components of TEV-50717. Patient has participated in an investigational drug or device study other than Study TV50717-CNS-30080 and received IMP/intervention within 30 days or 5 drug half-lives of day 1 of this study, whichever is longer. Patient is pregnant or breastfeeding. NOTE- Additional criteria apply, please contact the investigator for more information

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEV-50717<br>The dose of the TEV-50717 should be increased on a weekly basis to reach a clinically meaningful reduction in dyskinesia, as indicated by a reduction in the Clinical Global Impression of Improvement;(CGI-I). | Drug: TEV-50717<br>* Oral tablets are 6, 9, and 12 mg.<br>* Other names: Deutetrabenazine, SD-809;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Adverse events include clinically significant vital signs, ECG parameters, laboratory parameters | Up to 55 weeks | 
| Columbia-Suicide Severity Rating Scale | C-SSRS=Columbia-Suicide Severity Rating Scale scores assess suicidal ideation and behaviors | Baseline to Week 54 | 
| Extrapyramidal Symptom Rating Scale | Extrapyramidal Symptom Rating Scale (subscales I and II) scores assess four types of movement disorders | Baseline to Week 54 | 
| Child Behavior Checklist (CBCL) | Child Behavior Checklist (for ages 6 to 18) scores assess behavioral and emotional status in children | Baseline to Week 54 | 
| Epworth Sleepiness Scale | ESS = Epworth Sleepiness Scale (for children and adolescents) scores assess general level of daytime sleepiness | Baseline to Week 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder - Childhood Rating Scale Part I (centrally read) | MD-CRS=Movement Disorder- Childhood Rating Scale part I scores provide a general assessment of the movement disorder of motor function (minimum score 0, maximum score 60) | Baseline to Week 54 | 
| Movement Disorder - Childhood Rating Scale Part II (centrally read) | MD-CRS=Movement Disorder- Childhood Rating Scale part II scores provide a specific motor assessment of severity of the movement disorder (0 absent, 28 marked dyskinesia) | Baseline to Week 54 | 
| Movement Disorder - Childhood Rating Scale Part I | Total score (physician rated) MD-CRS=Movement Disorder- Childhood Rating Scale part I scores provide a general assessment of the movement disorder of motor function (minimum score 0, maximum score 60) | Baseline to Week 54 | 
| Movement Disorder - Childhood Rating Scale Part II | Total score (physician rated) MD-CRS=Movement Disorder- Childhood Rating Scale part II scores provide a specific motor assessment of severity of the movement disorder (0 absent, 28 marked dyskinesia) | Baseline to Week 54 | 
| Movement Disorder-Childhood Rating Scale Global Index | Calculated from MD-CRS parts I and II total scores. MD-CRS=Movement Disorder- Childhood Rating Scale Global Index is a child-oriented instrument to describe movement disorders. | Baseline to Week 54 | 
| Caregiver Global Impression of Improvement | CaGI-I=Caregiver Global Impression of Improvement (global, caregiver rated) scores reflect the impression of improvement in dyskinesia symptoms | Week 14 to Week 54 | 
| Clinical Global Impression of Improvement | CGI-I=Clinical Global Impression of Improvement (global, physician rated) scores reflect the investigator's assessment of overall improvement in dyskinesia symptoms | Week 1 to Week 55 | 
| Clinical Global Impression of Severity | CGI-S=Clinical Global Impression of Severity (global, physician rated) scores reflect the investigator's assessment of severity of dyskinesia symptoms | Baseline to Week 54 | 
| Pediatric Evaluation Disability Inventory-Computer Adapted Test | PEDI-CAT (activities of daily living, caregiver completed, content-balanced version) scores reflect the clinical assessment of functional activities | Baseline to Week 53 | 
| Unified Huntington's Disease Rating Scale-Total Maximal Chorea (centrally read) | UHDRS-TMC=Unified Huntington's Disease Rating Scale-Total Maximal Chorea | Baseline to Week 53 | 
| Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (centrally read) | UHDRS-TMD=Unified Huntington's Disease Rating Scale-Total Maximal Dystonia | Baseline to Week 53 | 
| Unified Huntington's Disease Rating Scale-Total Motor Score | Total score (physician rated) UHDRS-TMS=Unified Huntington's Disease Rating Scale-Total Motor Scores reflect the assessment of features associated with Huntington's Disease | Baseline to Week 53 | 
| Unified Huntington's Disease Rating Scale-Total Maximal Chorea | Total score (physician rated) UHDRS-TMC=Unified Huntington's Disease Rating Scale-Total Maximal Chorea | Baseline to Week 53 | 
| Unified Huntington's Disease Rating Scale-Total Maximal Dystonia | Total score (physician rated) UHDRS-TMD=Unified Huntington's Disease Rating Scale-Total Maximal Dystonia | Baseline to Week 53 | 
| Canadian Occupational Performance Measure | COPM=Canadian Occupational Performance Measure assesses patient outcomes in self-care, productivity, and leisure | Baseline to Week 53 |