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

• Status: Recruiting
• Trial end date: 2025-01-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Tetrabenazine

Criteria

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