NCT05695378

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Kainos Medicine Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Multiple System Atrophy

Interventions

Type	Name	Description
DRUG	KM-819	Subjects will receive KM-819 400 mg orally daily.
DRUG	Placebo	Subjects will receive Placebo orally daily.

Timeline

• Start date: 2023-02-27
• Primary completion: 2024-08-19
• Completion: 2024-08-19
• First posted: 2023-01-25
• Last updated: 2024-09-19

Locations

1 site across 1 country: South Korea