Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04680065
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2020-12-15
Brief Title:
GDNF Gene Therapy for Multiple System Atrophy
Sponsor:
Brain Neurotherapy Bio Inc
Organization:
Brain Neurotherapy Bio Inc
Study Overview
Official Title:
Randomized Double-Blind Placebo-controlled Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer AAV2-GDNF in Multiple System Atrophy
Status:
RECRUITING
Status Verified Date:
2024-10
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 objective of this randomized double-blinded placebo-controlled Phase 1 investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a possible or probable diagnosis of Multiple System Atrophy
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None