Sanda

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.

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.