Study of Oral TEV-56286 Capsules Compared to Placebo for Adults Aged 30 to 75 with Multiple System Atrophy

What this Trial Is About

Researchers are evaluating the oral drug TEV-56286 for treating adults aged 30 to 75 with Multiple System Atrophy MSA, a rare and progressive neurological disorder. This Phase 2, double-blind, placebo-controlled study aims to assess the drugs effectiveness, safety, and tolerability over 56 weeks, including screening, treatment, and follow-up. The study includes participants considered clinically possible or probable MSA based on specific criteria and is conducted across multiple countries. Participants will be randomly assigned to receive either TEV-56286 capsules or a matching placebo once daily by mouth during a 48-week double-blind treatment period. Before treatment, they undergo up to 4 weeks of screening, and after treatment, a follow-up visit occurs about 4 weeks later. The study spans approximately 27 months in total. During the trial, participants will have regular assessments including neurological and physical exams, clinical rating scales such as the Modified Unified Multiple System Atrophy Rating Scale UMSARS, MRI scans to measure brain structures, walking tests, and quality-of-life questionnaires. Researchers will monitor for treatment-emergent side effects and collect safety data through vital signs, lab tests, and ECGs. The main outcomes focus on changes in MSA symptoms and disease progression from baseline to week 48.

A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy