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

Phase 1

Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Dyskinesia in cerebral palsy (DCP)
MedDRA version: 21.1Level: PTClassification code 10013916Term: DyskinesiaSystem Organ Class: 10029205 - Nervous system disorders

Registration Number: EUCTR2019-001807-19-IT

Lead Sponsor: TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

Patients who have completed Study TV50717-CNS-30080 have already met the criteria below:
a. Patient ha completed parent Study TV50717-CNS-30080.
b. Patient weighs at least 12 kg (26 lb) on day 1 of this study.
c. Patient is able to swallow TEV-50717 tablet whole.
d. Patient and caregiver/adult are willing to adhere to TEV-50717 regimen and comply with all study procedures.
e. Patient is in good general health, as indicated by medical and psychiatric history and physical and neurological examination.
f. 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.
g. For a patient who is a minor, the parent(s)/legal guardian(s) provides written informed consent, and the patient provides assent (in accordance with local regulations). Adult patients (in accordance with local regulations) provide their own written informed consent.
h. A caregiver provides written informed consent after being assigned the role by an adult patient or if this role is delegated by the parent/legal guardian of a patient who is a minor.
i. 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will not be randomized/enrolled in this study if they meet any of the following criteria:
a. Patient has clinically significant depression at day 1 of this study. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose.
b. Patient has a history of suicidal intent or related behaviors: (i) previous intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought; (ii) previous suicidal preparatory acts or behaviour.
c. Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
d. Patient has a first-degree relative who has completed suicide.
e. 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. Food and Drug Administration-approved BoNT is to be defined as an FDA-approved compound, not necessarily an FDAapproved treatment for children. BoNT treatments other than FDAapproved drugs can be submitted to the medical monitor for consideration.
f. Patient has received any of the following concomitant medications for dystonia or chorea within the specified exclusionary windows of day 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.
g. 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.
h. 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.
i. 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.
j. 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.
k. Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
l. 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: Patients with abnormalities in 2 or more of the following clinical laboratory parameters must be approved for enrollment by the medical monitor: AST, ALT, ALP, and Tbil.
m. Patient has evidence of clinically significant renal impairment, indicated by a serum creatinine >1.5×ULN at day 1 of this study.
n. Patient has a known aller

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 longterm therapy with TEV-50717 in reducing the severity of DCP.;Primary end point(s): The safety measures/endpoints are as follows:<br>• adverse events<br>• vital signs<br>• children's C-SSRS (Columbia-Suicide Severity Rating Scale)<br>• ECG (electrocardiogram) parameters<br>• clinical laboratory parameters (hematology, serum chemistry, and urinalysis)<br>• ESRS (Extrapyramidal Symptom Rating Scale - subscales I and II)<br>• CBCL (Child Behaviour Checklist)<br>• ESS (Epworth Sleepiness Scale);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 Outcome Measures

Name	Time	Method

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