A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
Purpose
Study TV50717-CNS-30081 is a 55-week study in which participants 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
- Cerebral Palsy, Dyskinetic
Eligibility
- Eligible Ages
- Between 6 Years and 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant has completed parent Study TV50717-CNS-30080. - Participant weighs at least 12 kg (26 lb) on day 1 of this study. - Participant is able to swallow TEV-50717 whole. NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria
- Participant has clinically significant depression at screening or day 1 of this study. Note: Participants 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. - Participant 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 participant'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. - Participant has a history of a previous actual, interrupted, or aborted suicide attempt. - Participant has a first-degree relative who has completed suicide. - Participant has received any of the following concomitant Participant 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 - Participant 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 participant is not in a stable clinical condition. - Participants with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure. - Participant has a known allergy to any of the components of TEV-50717. - Participant 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. - Participant is pregnant or breastfeeding. NOTE- Additional criteria apply, please contact the investigator for more information
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
More Details
- Status
- Terminated
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.