drugset / Trial / NCT04200352

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

NCT04200352 ↗

Phase 3 Terminated 44 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
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

EvaluationDrugModalityDoseRoute
Subject TEV-50717 Unknown 6 mg Oral
Subject TEV-50717 Unknown 9 mg Oral
Subject TEV-50717 Unknown 12 mg Oral