3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Status Completed

Clinical Trial Summary

Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in patients with Amyotrophic Lateral Sclerosis (ALS).

Clinical Trial Description

This Phase 2 open label trial seeks to investigate whether a novel therapy named 3K3A-APC is safe and potentially effective in patients with Amyotrophic Lateral Sclerosis (ALS). A total of 16 patients with ALS will be enrolled into 2 dose cohorts with five doses of 15mg or 30mg doses given 12 hours apart in each cohort. The primary study outcomes are to ensure the safety and tolerability of 3K3AAPC in ALS patients, and to determine whether 3K3A-APC is able to reduce the pathological changes that might possibly cause ALS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05039268
Study type	Interventional
Source	Macquarie University, Australia
Contact
Status	Completed
Phase	Phase 2
Start date	November 25, 2021
Completion date	September 12, 2022

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