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

Primary Purpose

Cerebral Palsy, Dyskinetic

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TEV-50717
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Dyskinetic

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teva Investigational Site 14137
  • Teva Investigational Site 14295
  • Teva Investigational Site 14122
  • Teva Investigational Site 14299
  • Teva Investigational Site 14129
  • Teva Investigational Site 39058
  • Teva Investigational Site 80146
  • Teva Investigational Site 80147
  • Teva Investigational Site 30214
  • Teva Investigational Site 30216
  • Teva Investigational Site 53434
  • Teva Investigational Site 53428
  • Teva Investigational Site 53427
  • Teva Investigational Site 53430
  • Teva Investigational Site 50477
  • Teva Investigational Site 50475
  • Teva Investigational Site 50470
  • Teva Investigational Site 50485
  • Teva Investigational Site 50468
  • Teva Investigational Site 50469
  • Teva Investigational Site 50478
  • Teva Investigational Site 50474
  • Teva Investigational Site 31254
  • Teva Investigational Site 58313
  • Teva Investigational Site 58309
  • Teva Investigational Site 58311
  • Teva Investigational Site 58310
  • Teva Investigational Site 34245
  • Teva Investigational Site 34243
  • Teva Investigational Site 34244

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TEV-50717

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)
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)
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.
Caregiver Global Impression of Improvement
CaGI-I=Caregiver Global Impression of Improvement (global, caregiver rated) scores reflect the impression of improvement in dyskinesia symptoms
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
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
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
Unified Huntington's Disease Rating Scale-Total Maximal Chorea (centrally read)
UHDRS-TMC=Unified Huntington's Disease Rating Scale-Total Maximal Chorea
Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (centrally read)
UHDRS-TMD=Unified Huntington's Disease Rating Scale-Total Maximal Dystonia
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
Unified Huntington's Disease Rating Scale-Total Maximal Chorea
Total score (physician rated) UHDRS-TMC=Unified Huntington's Disease Rating Scale-Total Maximal Chorea
Unified Huntington's Disease Rating Scale-Total Maximal Dystonia
Total score (physician rated) UHDRS-TMD=Unified Huntington's Disease Rating Scale-Total Maximal Dystonia
Canadian Occupational Performance Measure
COPM=Canadian Occupational Performance Measure assesses patient outcomes in self-care, productivity, and leisure

Full Information

First Posted
December 12, 2019
Last Updated
March 9, 2023
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04200352
Brief Title
A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
February 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Dyskinetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEV-50717
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
TEV-50717
Other Intervention Name(s)
Deutetrabenazine, SD-809
Intervention Description
Oral tablets are 6, 9, and 12 mg.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Adverse events include clinically significant vital signs, ECG parameters, laboratory parameters
Time Frame
Up to 55 weeks
Title
Columbia-Suicide Severity Rating Scale
Description
C-SSRS=Columbia-Suicide Severity Rating Scale scores assess suicidal ideation and behaviors
Time Frame
Baseline to Week 54
Title
Extrapyramidal Symptom Rating Scale
Description
Extrapyramidal Symptom Rating Scale (subscales I and II) scores assess four types of movement disorders
Time Frame
Baseline to Week 54
Title
Child Behavior Checklist (CBCL)
Description
Child Behavior Checklist (for ages 6 to 18) scores assess behavioral and emotional status in children
Time Frame
Baseline to Week 54
Title
Epworth Sleepiness Scale
Description
ESS = Epworth Sleepiness Scale (for children and adolescents) scores assess general level of daytime sleepiness
Time Frame
Baseline to Week 54
Secondary Outcome Measure Information:
Title
Movement Disorder - Childhood Rating Scale Part I (centrally read)
Description
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)
Time Frame
Baseline to Week 54
Title
Movement Disorder - Childhood Rating Scale Part II (centrally read)
Description
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)
Time Frame
Baseline to Week 54
Title
Movement Disorder - Childhood Rating Scale Part I
Description
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)
Time Frame
Baseline to Week 54
Title
Movement Disorder - Childhood Rating Scale Part II
Description
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)
Time Frame
Baseline to Week 54
Title
Movement Disorder-Childhood Rating Scale Global Index
Description
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.
Time Frame
Baseline to Week 54
Title
Caregiver Global Impression of Improvement
Description
CaGI-I=Caregiver Global Impression of Improvement (global, caregiver rated) scores reflect the impression of improvement in dyskinesia symptoms
Time Frame
Week 14 to Week 54
Title
Clinical Global Impression of Improvement
Description
CGI-I=Clinical Global Impression of Improvement (global, physician rated) scores reflect the investigator's assessment of overall improvement in dyskinesia symptoms
Time Frame
Week 1 to Week 55
Title
Clinical Global Impression of Severity
Description
CGI-S=Clinical Global Impression of Severity (global, physician rated) scores reflect the investigator's assessment of severity of dyskinesia symptoms
Time Frame
Baseline to Week 54
Title
Pediatric Evaluation Disability Inventory-Computer Adapted Test
Description
PEDI-CAT (activities of daily living, caregiver completed, content-balanced version) scores reflect the clinical assessment of functional activities
Time Frame
Baseline to Week 53
Title
Unified Huntington's Disease Rating Scale-Total Maximal Chorea (centrally read)
Description
UHDRS-TMC=Unified Huntington's Disease Rating Scale-Total Maximal Chorea
Time Frame
Baseline to Week 53
Title
Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (centrally read)
Description
UHDRS-TMD=Unified Huntington's Disease Rating Scale-Total Maximal Dystonia
Time Frame
Baseline to Week 53
Title
Unified Huntington's Disease Rating Scale-Total Motor Score
Description
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
Time Frame
Baseline to Week 53
Title
Unified Huntington's Disease Rating Scale-Total Maximal Chorea
Description
Total score (physician rated) UHDRS-TMC=Unified Huntington's Disease Rating Scale-Total Maximal Chorea
Time Frame
Baseline to Week 53
Title
Unified Huntington's Disease Rating Scale-Total Maximal Dystonia
Description
Total score (physician rated) UHDRS-TMD=Unified Huntington's Disease Rating Scale-Total Maximal Dystonia
Time Frame
Baseline to Week 53
Title
Canadian Occupational Performance Measure
Description
COPM=Canadian Occupational Performance Measure assesses patient outcomes in self-care, productivity, and leisure
Time Frame
Baseline to Week 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 14137
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Teva Investigational Site 14295
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Teva Investigational Site 14122
City
Gibbsboro
State/Province
New Jersey
ZIP/Postal Code
08026
Country
United States
Facility Name
Teva Investigational Site 14299
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Teva Investigational Site 14129
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Teva Investigational Site 39058
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Teva Investigational Site 80146
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Teva Investigational Site 80147
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Teva Investigational Site 30214
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Teva Investigational Site 30216
City
Pisa
ZIP/Postal Code
56018
Country
Italy
Facility Name
Teva Investigational Site 53434
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Teva Investigational Site 53428
City
Gdansk
ZIP/Postal Code
80-389
Country
Poland
Facility Name
Teva Investigational Site 53427
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Teva Investigational Site 53430
City
Wiazowna
ZIP/Postal Code
05-462
Country
Poland
Facility Name
Teva Investigational Site 50477
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Teva Investigational Site 50475
City
Khabarovsk
ZIP/Postal Code
680021
Country
Russian Federation
Facility Name
Teva Investigational Site 50470
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Teva Investigational Site 50485
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Teva Investigational Site 50468
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Teva Investigational Site 50469
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Teva Investigational Site 50478
City
Stavropol
ZIP/Postal Code
355029
Country
Russian Federation
Facility Name
Teva Investigational Site 50474
City
Tyumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Teva Investigational Site 31254
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Teva Investigational Site 58313
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Teva Investigational Site 58309
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Teva Investigational Site 58311
City
Odesa
ZIP/Postal Code
65012
Country
Ukraine
Facility Name
Teva Investigational Site 58310
City
Vinnytsya
ZIP/Postal Code
21037
Country
Ukraine
Facility Name
Teva Investigational Site 34245
City
Edinburgh
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Teva Investigational Site 34243
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Teva Investigational Site 34244
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)

Learn more about this trial

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

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