NCT04200352

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

An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy, Dyskinetic

Interventions

Type	Name	Description
DRUG	TEV-50717	Oral tablets are 6, 9, and 12 mg.

Timeline

• Start date: 2020-02-04
• Primary completion: 2023-02-14
• Completion: 2023-02-14
• First posted: 2019-12-16
• Last updated: 2024-04-22
• Results posted: 2024-04-22

Locations

30 sites across 9 countries: United States, Denmark, Israel, Italy, Poland, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study