Open-Label Phase 2 Study of Oral TEV-56286 for Safety and Effectiveness 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 adults with Multiple System Atrophy MSA. This Phase 2 open-label extension trial aims to describe how well participants tolerate TEV-56286 over approximately 100 weeks. The study focuses on understanding adverse events and withdraw rates related to the drug. Participants receive TEV-56286 orally throughout the trial period. This trial follows completion of a prior double-blind study and continues monitoring participants for safety and tolerability. The trial is designed as a single group study, where all participants receive the investigational drug without a comparator or placebo. During the trial, participants undergo regular assessments including monitoring for adverse events, vital signs, laboratory tests, and ECG measurements up to week 96. Researchers track the number of participants experiencing adverse events and those withdrawing due to such events over the 100-week duration. The study also carefully monitors laboratory and ECG changes to evaluate safety and tolerability.

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