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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04200352
Collaborator
(none)
185
Enrollment
35
Locations
1
Arm
43.1
Anticipated Duration (Months)
5.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
185 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 4, 2020
Anticipated Primary Completion Date :
Sep 9, 2023
Anticipated Study Completion Date :
Sep 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TEV-50717

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
Oral tablets are 6, 9, and 12 mg.
Other Names:
  • Deutetrabenazine, SD-809

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events [Up to 55 weeks]

      Adverse events include clinically significant vital signs, ECG parameters, laboratory parameters

    2. Columbia-Suicide Severity Rating Scale [Baseline to Week 54]

      C-SSRS=Columbia-Suicide Severity Rating Scale scores assess suicidal ideation and behaviors

    3. Extrapyramidal Symptom Rating Scale [Baseline to Week 54]

      Extrapyramidal Symptom Rating Scale (subscales I and II) scores assess four types of movement disorders

    4. Child Behavior Checklist (CBCL) [Baseline to Week 54]

      Child Behavior Checklist (for ages 6 to 18) scores assess behavioral and emotional status in children

    5. Epworth Sleepiness Scale [Baseline to Week 54]

      ESS = Epworth Sleepiness Scale (for children and adolescents) scores assess general level of daytime sleepiness

    Secondary Outcome Measures

    1. Movement Disorder - Childhood Rating Scale Part I [Baseline to Week 54]

      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)

    2. Movement Disorder - Childhood Rating Scale Part II [Baseline to Week 54]

      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)

    3. Movement Disorder-Childhood Rating Scale Global Index [Baseline to Week 54]

      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.

    4. Caregiver Global Impression of Improvement [Week 14 to Week 54]

      CaGI-I=Caregiver Global Impression of Improvement (global, caregiver rated) scores reflect the impression of improvement in dyskinesia symptoms

    5. Clinical Global Impression of Improvement [Week 1 to Week 55]

      CGI-I=Clinical Global Impression of Improvement (global, physician rated) scores reflect the investigator's assessment of overall improvement in dyskinesia symptoms

    6. Clinical Global Impression of Severity [Baseline to Week 54]

      CGI-S=Clinical Global Impression of Severity (global, physician rated) scores reflect the investigator's assessment of severity of dyskinesia symptoms

    7. Pediatric Evaluation Disability Inventory-Computer Adapted Test [Baseline to Week 53]

      PEDI-CAT (activities of daily living, caregiver completed, content-balanced version) scores reflect the clinical assessment of functional activities

    8. Unified Huntington's Disease Rating Scale-Total Motor Score [Baseline to Week 53]

      UHDRS-TMS=Unified Huntington's Disease Rating Scale-Total Motor Scores reflect the assessment of features associated with Huntington's Disease

    9. Unified Huntington's Disease Rating Scale-Total Maximal Chorea [Baseline to Week 53]

      UHDRS-TMC=Unified Huntington's Disease Rating Scale-Total Maximal Chorea

    10. Unified Huntington's Disease Rating Scale-Total Maximal Dystonia [Baseline to Week 53]

      UHDRS-TMD=Unified Huntington's Disease Rating Scale-Total Maximal Dystonia

    11. Canadian Occupational Performance Measure [Baseline to Week 53]

      COPM=Canadian Occupational Performance Measure assesses patient outcomes in self-care, productivity, and leisure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion:

    • 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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teva Investigational Site 14137 Birmingham Alabama United States 35233
    2 Teva Investigational Site 14295 San Diego California United States 92123
    3 Teva Investigational Site 14122 Voorhees New Jersey United States 08043
    4 Teva Investigational Site 14299 Charleston South Carolina United States 29414
    5 Teva Investigational Site 14129 Nashville Tennessee United States 37232
    6 Teva Investigational Site 39058 Copenhagen Denmark 2100
    7 Teva Investigational Site 80146 Tel-Aviv Israel 64239
    8 Teva Investigational Site 80147 Zerifin Israel 70300
    9 Teva Investigational Site 30214 Milan Italy 20133
    10 Teva Investigational Site 30216 Pisa Italy 56018
    11 Teva Investigational Site 53426 Chodziez Poland 64-800
    12 Teva Investigational Site 53428 Gdansk Poland 80-389
    13 Teva Investigational Site 53434 Gdansk Poland 80-952
    14 Teva Investigational Site 53427 Krakow Poland 30-539
    15 Teva Investigational Site 53432 Poznan Poland 60-693
    16 Teva Investigational Site 53430 Wiazowna Poland 05-462
    17 Teva Investigational Site 50477 Kazan Russian Federation 420021
    18 Teva Investigational Site 50475 Khabarovsk Russian Federation 680013
    19 Teva Investigational Site 50473 Moscow Russian Federation 117513
    20 Teva Investigational Site 50470 Moscow Russian Federation 129110
    21 Teva Investigational Site 50485 Nizhniy Novgorod Russian Federation 603126
    22 Teva Investigational Site 50468 Novosibirsk Russian Federation 630047
    23 Teva Investigational Site 50469 Smolensk Russian Federation 214018
    24 Teva Investigational Site 50478 Stavropol, Stavropol Krai Region Russian Federation 355000
    25 Teva Investigational Site 50474 Tyumen Russian Federation 625023
    26 Teva Investigational Site 31254 Valencia Spain 46026
    27 Teva Investigational Site 58313 Dnipropetrovsk Ukraine 49101
    28 Teva Investigational Site 58309 Kyiv Ukraine 4209
    29 Teva Investigational Site 58311 Odessa Ukraine 65012
    30 Teva Investigational Site 58314 Uzhgorod Ukraine 88018
    31 Teva Investigational Site 58310 Vinnytsa Ukraine 21005
    32 Teva Investigational Site 34245 Edinburgh United Kingdom EH9 1LF
    33 Teva Investigational Site 34243 London United Kingdom SE1 7EH
    34 Teva Investigational Site 34247 Norwich United Kingdom NR4 7UY
    35 Teva Investigational Site 34244 Sheffield United Kingdom S10 2TH

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

    • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT04200352
    Other Study ID Numbers:
    • TV50717-CNS-30081
    • 2019-001807-19
    First Posted:
    Dec 16, 2019
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cerebral Palsy

    Study Results

    No Results Posted as of Jul 11, 2022