Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645197
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
An IIT Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of a Single Intrathecal Injection of SNUG01 in Patients with Amyotrophic Lateral Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Single-Arm Open-Label IIT Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of a Single Intrathecal Injection of SNUG01 in Patients with Amyotrophic Lateral Sclerosis ALS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALS
Brief Summary:
This is a multicenter open-label single-arm investigator-initiated clinical study designed to evaluate the safety tolerability and preliminary efficacy of SNUG01 in patients with Amyotrophic Lateral Sclerosis ALS
Detailed Description:
SNUG01 is a gene therapy designed to deliver a protective protein gene to the central nervous system Safety will be the primary focus during the initial 24 weeks post-treatment primary study period After the primary study period participants will be assessed for both safety and efficacy for up to a total of 5 years following SNUG01 treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None