An Open-Label Extension Trial to Describe Safety and Efficacy of TEV-56286 in Adults With Multiple System Atrophy

What this Trial Is About

Researchers are evaluating the long-term safety and tolerability of TEV-56286, an oral drug, in adult participants with Multiple System Atrophy (MSA). This Phase 2 trial aims to describe how participants tolerate the treatment over approximately 100 weeks and to further understand the drug's safety profile during this extended period. Participants receive TEV-56286 orally throughout the study. The trial is open-label and multi-centered, lasting about 100 weeks. The study focuses on monitoring adverse events and reasons for withdrawal related to treatment. Secondary safety measures include checking vital signs, laboratory tests, and heart monitoring using 12-lead ECGs over roughly 96 weeks. During the trial, participants undergo regular assessments to track safety and tolerability. Researchers monitor adverse events, vital signs, lab results, and cardiac measurements. The study tracks participants from baseline through week 100, including reasons for any withdrawals due to adverse events. The overall involvement spans nearly two years, aiming to gather comprehensive long-term safety data.

An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy