Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 8:53 PM
Study NCT ID:
NCT07088159
Status:
AVAILABLE
Last Update Posted:
2025-12-17
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermediate-size Patient Population Expanded Access Protocol
Sponsor:
Spinogenix
Organization:
Study Overview
Official Title:
Intermediate-size Patient Population Expanded Access Protocol for SPG302 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)
Status:
AVAILABLE
Status Verified Date:
2025-12
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:
The purpose of this Expanded Access Program is to provide SPG302 to ALS patients who are not eligible to enroll in an ALS clinical trial. This Expanded Access Program will assess safety and tolerability, and clinical efficacy of SPG302.
Detailed Description:
This is a multi-site, intermediate-size patient population expanded access protocol developed to provide compassionate use access to SPG302 to adult patients with ALS who have progressed following available standard of care.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: