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Trial record 1 of 1 for:    NCT03813238
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A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (RECLAIM-DCP)

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ClinicalTrials.gov Identifier: NCT03813238
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )

Brief Summary:

CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. CP is caused by damage to or abnormalities inside the developing brain that disrupt the brain's ability to control movement and maintain posture and balance. The signs of CP usually appear in the early months of life, although specific diagnosis may be delayed until the age of 2 years or older. TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for safe and effective use in 2 other hyperkinetic movement disorders, namely chorea in Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive CP symptoms since infancy (≤2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria.

This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder. The study will be conducted in multiple centers and will use 2 parallel treatment groups (ie, TEV-50717 and placebo) in which participants will be randomized in a 2:1 ratio.

"Predominant" in this instance indicates that the choreiform movement disorder is the main cause of impairment or distress.


Condition or disease Intervention/treatment Phase
Cerebral Palsy, Dyskinetic Drug: Deutetrabenazine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : September 27, 2021
Estimated Study Completion Date : September 27, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deutetrabenazine
administered as oral tablets at a starting dose of 6 mg once daily
Drug: Deutetrabenazine
Dosage ranging from 6 mg to 48 mg.
Other Name: TEV-50717, (previously SD-809)

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Dosage ranging from 6 mg to 48 mg.




Primary Outcome Measures :
  1. Change in the MD-CRS part II [ Time Frame: Baseline to Week 15 ]

    MD-CRS part II: Movement Disorder-Childhood Rating Scale part II total score (movement disorder severity, centrally read) (TEV-50717 versus placebo).

    Assesses the severity of abnormal hyperkinetic movement disorders in the 7 body regions using a 0 to 4 scale. Zero corresponds to no signs, and 4 corresponds to the most severe findings.



Secondary Outcome Measures :
  1. Change in the MD-CRS part I [ Time Frame: Baseline to Week 15 ]

    Key secondary efficacy endpoint- MD-CRS part I: Movement Disorder-Childhood Rating Scale part I total score (general assessment, centrally read) (TEV-50717 versus placebo).

    Evaluates impact of DCP on the activities of the patient and provides a general assessment of the movement disorder of motor function (7 items), oral/verbal function (3 items), self-care (3 items), and attention/alertness (2 items) on a scale of 0 (present) to 4 (absent)


  2. CaGI-I Scale [ Time Frame: Week 15 ]

    Key secondary efficacy endpoint- CaGI-I Scale: Caregiver Global Impression of Improvement (TEV-50717 versus placebo).

    A single item questionnaire to assess the caregiver's impression of improvement in dyskinesia symptoms after initiating therapy. Scaled from 1 (very much improved) to 7 (very much worse).


  3. CGI-I Scale [ Time Frame: Week 15 ]

    Key secondary efficacy endpoint- CGI-I Scale: Clinical Global Impression of Improvement (TEV-50717 versus placebo).

    A single item questionnaire to assess the caregiver's impression of improvement in dyskinesia symptoms after initiating therapy. Scaled from 1 (very much improved) to 7 (very much worse).


  4. Change in MD-CRS Global Index calculated from MD-CRS parts I and II total scores [ Time Frame: Baseline to Week 15 ]
    A global measure of the MD-CRS that consolidates the information from parts I and II using the method of weighted means of the 2 normalized indexes obtained from each part. The minimum score is 0 and the maximum score is 1

  5. Change in UHDRS-TMS [ Time Frame: Baseline to Week 15 ]

    Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS-TMS).

    A broad assessment of features associated with HD. The TMS component of UHDRS comprises 31 assessments from the 15 items of the UHDRS. The TMS is calculated as the sum of the 31 motor assessments, each of which range between 0 to 4.


  6. Change in UHDRS-TMC [ Time Frame: Baseline to Week 15 ]

    Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC).

    Part of the UHDRS-TMS assessment and assesses the severity of chorea in the face, mouth, trunk, and the 4 extremities. The minimum score is 0 (absent) and the maximum score is 28


  7. Change in UHDRS-TMD [ Time Frame: Baseline to Week 15 ]

    Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (UHDRS-TMD).

    Part of the UHDRS-TMS assessment and assesses the severity of dystonia in the trunk and the 4 extremities. The minimum score is 0 (absent) and the maximum score is 20 (marked/prolonged).


  8. Change in PEDI-CAT (ADL, parent/caregiver completed, content balanced version) [ Time Frame: Baseline and Week 15 ]

    Pediatric Evaluation Disability Inventory-Computer Adapted Test (PEDI-CAT).

    The scaled scores are based on an estimate of the placement of an individual child along the hierarchical scale within each domain. The PEDI-CAT scaled scores are currently on a 20 to 80 scale metric.


  9. Change in the cerebral palsy (CP) module of the PedsQL (QoL, patient/caregiver) [ Time Frame: Baseline and Week 15 ]

    A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows:

    0=never a problem;

    1. almost never a problem;
    2. sometimes a problem;
    3. often a problem;
    4. almost always a problem.

  10. Change in PGI-I Scale (global, patient/caregiver) [ Time Frame: Week 3 to Week 15 ]

    Patient Global Impression of Improvement (PGI-I).

    A single item questionnaire to assess the patient's impression of improvement in dyskinesia symptoms after initiating therapy.

    1. much improved (since the initiation of treatment);
    2. somewhat improved;
    3. no change;
    4. somewhat worse;
    5. much worse (since the initiation of treatment).

  11. Change in CGI-S Scale (global, physician rated) [ Time Frame: Screening to Week 16 ]

    Clinical Global Impression of Severity (CGI-S).

    Uses a 7-point Likert scale to assess dyskinesia severity as follows:

    1=normal, 2=borderline, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extreme.


  12. Change in CaGI-I response [ Time Frame: Week 3 to Week 16 ]
    Defined as participants who are described by the caregiver as "Much Improved" or "Very Much Improved" in the CaGI-I score

  13. Change in CGI-I response [ Time Frame: Week 1 to Week 16 ]
    Defined as participants who are described as "Much Improved" or "Very Much Improved" in the CGI-I score

  14. Change in CGI-S response [ Time Frame: Week 3 to Week 16 ]
    Defined as participants who have a reduction of ≥1 point in the CGI-S score

  15. Change is PGI-I response [ Time Frame: Week 3 to Week 16 ]
    Defined as participants who are described as "Much Improved" or "Somewhat Improved" in the PGI-I score

  16. Percentage of Participants with Adverse Events [ Time Frame: Screening to Week 17 ]
    The safety variables include adverse events (and the number of participants who withdraw from the study due to adverse events)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is 6 through 18 years of age (inclusive) at baseline.
  • Participant weighs at least 26 pounds (12 kg) at baseline.
  • Participant has had CP symptoms since infancy (≤2 years)
  • Choreiform is the prevalent movement disorder as assessed by the EAB at screening.
  • Participant has a diagnosis of DCP
  • Participant is able to swallow study medication whole.
  • 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
  • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • Participant has a predominant movement disorder other than dyskinesia.
  • Participant's predominant motor symptoms are dystonic.
  • Participant's predominant motor symptoms are spastic.
  • Participant has choreiform movement disorder that has not been consistent throughout the life of the participant..
  • Participant has clinically significant depression at screening or baseline.
  • Note: Participants receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening.
  • Participant 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
  • Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
  • Participant has a first-degree relative who has completed suicide.
  • Participant who is currently receiving or who, in the last 4 months, has received botulinum neurotoxin (BoNT) in an investigational clinical trial.
  • Participant has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP within 6 months of the screening visit, or the participant is not in a stable clinical condition.
  • Participant has recent surgical procedure or is anticipated to have a surgical procedure during the study that, in the opinion of the investigator, makes the Participant unsuitable for the study.
  • Participant has a severe mental disability or an unstable or serious medical illness (eg, epilepsy) at screening or baseline that, in the opinion of the investigator, could jeopardize or would compromise the Participant's ability to participate in this study.
  • Participant has a known allergy to any of the components of the IMP.
  • Participant is pregnant or breastfeeding.
  • Participant has a history of or acknowledges alcohol or substance abuse in the 12 months before screening
  • Participants with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
  • Additional criteria apply, please contact the investigator for more information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813238


Contacts
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Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

Locations
Show Show 53 study locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT03813238    
Other Study ID Numbers: TV50717-CNS-30080
2018-003742-17 ( EudraCT Number )
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. ):
DCP
Additional relevant MeSH terms:
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Cerebral Palsy
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Movement Disorders