drugset / Trial / NCT04200352
A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-02-04
- Primary completion
- 2023-02-14
- Completion
- 2023-02-14
Outcome
Outcome not reported
Stopped: “Failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TEV-50717 | Unknown | 6 mg | Oral |
| Subject | TEV-50717 | Unknown | 9 mg | Oral |
| Subject | TEV-50717 | Unknown | 12 mg | Oral |