Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05039268
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2021-08-23
Brief Title:
3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis ALS
Sponsor:
Macquarie University Australia
Organization:
Macquarie University Australia
Study Overview
Official Title:
A Phase 2 Open Label Trial of 3K3A-APC in Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in patients with Amyotrophic Lateral Sclerosis ALS
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None