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Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA)

Multiple System Atrophy Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy

Clinical Trial Summary

This trial will the efficacy of KM-819 compared to placebo in subjects with MSA for slowing the progression of MSA.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled phase II trial. This trial will be performed in two part: Main study and Ancillary study. Main Study: Following a 4-week screening period, subjects will be stratified by MSA subtype (MSA-P, -C [MSA-Parkinsonian type, MSA-cerebellar ataxia]) and randomly assigned in a 1:1 ratio either to KM-819 or Placebo groups. During a treatment period of 36 weeks, subjects will receive pills of either KM-819 or Placebo for oral administration every day from baseline visit. Following this, there will be a safety follow-up period at Week 40. Ancillary Study: This ancillary study will provide additional information on the continuing efficacy and safety of KM-819. Subjects in either treatment group in the main study who complete the study are eligible to participate in a follow-up, all-subjects-on-treatment (KM-819), open-label ancillary study. All subjects in the ancillary study will receive KM-819 for additional 36 weeks regardless of their treatment allocation during the main study. During a treatment period of 36 weeks, subjects will receive pills of KM-819 for oral administration every day from visit at Weeks 40. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05695378
Study type Interventional
Source Kainos Medicine Inc.
Contact JAE MOON LEE
Phone +82-2-567-7419
Email Jlee@kainosmedicine.com
Status Recruiting
Phase Phase 2
Start date February 27, 2023
Completion date November 18, 2024
View Details
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