Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965700
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-07-16
Brief Title:
NVG-291 in Spinal Cord Injury Subjects
Sponsor:
NervGen Pharma
Organization:
NervGen Pharma
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 1b2a Study of NVG-291 in Spinal Cord Injury Subjects
Status:
RECRUITING
Status Verified Date:
2024-03
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:
A Single site Shirley Ryan AbilityLab Randomized Double-Blind Placebo-Controlled Phase 1b2a Study of NVG-291 in Spinal Cord Injury Subjects
Detailed Description:
To evaluate the effect of NVG-291 on descending connectivity in subjects with subacute and chronic SCI 20 subjects per Cohort and results will be analyzed separately using objective electrophysiological measures in addition to clinical assessments To evaluate safety and tolerability of NVG-291 in a SCI population as measured by clinical assessments Physical Examination Vital Signs ECG etc as well as clinical laboratory measures
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