NVG-291 in Spinal Cord Injury Subjects
A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2a Study of NVG-291 in Spinal Cord Injury Subjects (CONNECT)
1 other identifier
interventional
40
1 country
1
Brief Summary
A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2a Study of NVG-291 in Spinal Cord Injury Subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2023
CompletedFirst Posted
Study publicly available on registry
July 28, 2023
CompletedStudy Start
First participant enrolled
August 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedMarch 6, 2026
March 1, 2026
2.6 years
July 16, 2023
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Electrophysiological
MEP amplitudes (corticospinal contribution) in key target muscle groups
12 weeks
Secondary Outcomes (8)
10mWT time
12 weeks
9-HPT time
12 weeks
Dynamometry testing (pinch grip, Chronic cohort 1; hand grip, Subacute cohort 2)
12 weeks
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test
12 weeks
Lower extremity motor score (LEMS)
12 weeks
- +3 more secondary outcomes
Study Arms (2)
NVG-291 for Injection
EXPERIMENTALInjected under the skin (subcutaneous).
Placebo
PLACEBO COMPARATORInjected under the skin (subcutaneous).
Interventions
Eligibility Criteria
You may qualify if:
- A subject must provide written informed consent in accordance with local regulations prior to initiation of any study-specific activities/procedures. A legally authorized representative (LAR) may be used to assist in signing the informed consent.
- Cervical SCI resulting from acute physical trauma.
- Males and females
- Age 18 - 75 years, inclusive.
- Cervical SCI, incomplete, with a neurological level of injury being at C7 or higher.
- Had incomplete cervical SCI within the period from 1 year to 10 years inclusive (Chronic cohort 1) OR within 20 days to 90 days inclusive (Subacute cohort 2) at time of randomization.
- Must be able to volitionally initiate at least one step on one leg (without body weight support). (Cohort 1 only)
- Must have a Walking Index for Spinal Cord Injury II (WISCI II) score as follows:
- For Chronic cohort 1: Less than or equal to Level 14.
- For Subacute cohort 2: Less than or equal to Level 10.
- GRASSP/hand grip strength Prehension Ability score
- For Chronic cohort 1:
- i. Must have a score of at least 2 on at least one of the Prehension Ability grasp patterns of the GRASSP assessment in at least one upper extremity. ii. Must have no more than one Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion i
- For Subacute cohort 2:
- i. Must have some voluntary (nonzero) force measured by grip dynamometry in at least one upper extremity.
- +7 more criteria
You may not qualify if:
- Nontraumatic SCI (e.g., due to infection, ischemia, metabolic abnormality, congenital abnormality, malignancy, radiation injury, surgical complications, or other disease process).
- Spinal cord injury due to gunshot wound or penetrating injury.
- Two or more (noncontiguous) spinal cord lesions.
- MRI or CT evidence of anatomically complete spinal cord transection.
- Any form of ventilatory dependence.
- Any condition that precludes adequate clinical assessment of all four extremities, such as contracture, peripheral nerve injury, amputation.
- History of uncontrolled seizures or any seizure within the last 6 months (Cohort 1). History of uncontrolled seizures, or any seizure occurring 1 week or more after the SCI (Cohort 2)
- Metal implant in the head that is likely to interfere with MRI analysis.
- Pregnant or breast feeding.
- Any neurological condition that is considered to interfere with performance or likly confound assessment, such as multiple sclerosis, stroke, or progressive syringomyelia.
- History of substance abuse within 12 months prior to screening, based on medical records or self-report.
- Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma.
- Prior treatment with cell therapy delivered into the CNS (intrathecal or intraparenchymal).
- Severe neuropathic pain inadequately controlled by medication.
- Body mass index (BMI) \> 40 (body weight in kilograms divided by height in meters squared).
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NervGen Pharmalead
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
Related Publications (1)
Hosseini SM, Stecina K, Nemati S, Wang RR, Zhang JV, Karimi-Abdolrezaee S. Circuit Reconstruction after Traumatic Spinal Cord Injury by Cellular and Pharmacological Approaches. J Neurosci. 2025 Aug 27;45(35):e0362252025. doi: 10.1523/JNEUROSCI.0362-25.2025.
PMID: 40744729DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Randall Kaye, M.D.
NervGen Pharma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2023
First Posted
July 28, 2023
Study Start
August 8, 2023
Primary Completion
March 1, 2026
Study Completion
April 1, 2026
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share