A Study of TAK-341 in Treatment of Multiple System Atrophy

Summary

The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS). The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed. This trial will be conducted in North America, Europe and Asia.

Timeline

Start

2022-11-16

Primary completion

2025-07-28

Completion

2025-07-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs TAK-341; p =0.961; Least Square (LS) Mean Difference -0.04 (95% CI -1.78 to 1.69); Linear Mixed Effects Model NCT05526391 ↗

Drugs

Indications