NVG-291 for Spinal Cord Injury

Overseen By Tom Feinberg

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NervGen Pharma

Must not be taking: Opioids, 4-aminopyridine

Disqualifiers: Nontraumatic SCI, Seizures, Substance abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called NVG-291 to see if it can help people with spinal cord injuries. The study focuses on those with injuries that haven't fully healed. NVG-291 aims to improve nerve communication in the spinal cord, potentially leading to better movement and sensation.

Will I have to stop taking my current medications?

The trial protocol does not clearly specify if you must stop taking your current medications. However, you cannot participate if you have taken certain medications recently, like 4-aminopyridine within 14 days or any non-permitted medication within 5.5 half-lives or 7 days before randomization.

What data supports the effectiveness of the drug NVG-291 for spinal cord injury?

Research on a similar treatment, bisperoxovanadium (bpV), shows it can protect nerve cells and help recovery after spinal cord injuries by activating certain cell survival pathways. This suggests that NVG-291, which may work in a similar way, could also be effective for spinal cord injury. ^{1 2 3 4 5}

Research Team

Daniel Mikol, M.D. Ph.D.

Principal Investigator

NervGen Pharma

Eligibility Criteria

This trial is for adults aged 18-75 with incomplete cervical spinal cord injury from physical trauma, able to take at least one step and have some hand grasp ability. They must be fluent in English, willing to follow the study plan, and not involved in another clinical trial or have certain medical conditions like severe pain, high BMI, or recent substance abuse.

Inclusion Criteria

Must be fluent in English.

My spinal cord injury in the neck was caused by a sudden injury.

I have given or will give my written consent to participate.

Exclusion Criteria

Any implanted internal spinal cord stimulator.

I use opioids through spinal injection.

I have taken 4-aminopyridine in the last 14 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NVG-291 or placebo injections subcutaneously to evaluate safety, tolerability, and effects on descending connectivity in spinal cord injury subjects

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidences of treatment emergent adverse events

4 weeks

Treatment Details

Interventions

• NVG-291

Trial Overview The study tests NVG-291 on people with spinal cord injuries. It's a randomized (people are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), placebo-controlled (compared against an inactive substance) trial at Shirley Ryan AbilityLab.

Participant Groups

Group I: NVG-291 for Injection Experimental Treatment 1 Intervention

Injected under the skin (subcutaneous).

Group II: Placebo Placebo Group 1 Intervention

Injected under the skin (subcutaneous).

Who Is Running the Clinical Trial?

NervGen Pharma

Lead Sponsor

Trials

2

Recruited

110+

Findings from Research

In a study of 2807 patients with nontraumatic spinal cord injuries (NTSCI), the most common injury type was incomplete cervical level injury, with a significant number of patients experiencing hospital-acquired complications, particularly falls.

Factors such as older age, higher comorbidity index, and ICU stays were linked to poorer outcomes, including increased odds of non-home discharge and higher in-hospital mortality, highlighting the need for careful management of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical characteristics, hospital course, and disposition of patients with nontraumatic spinal cord injury in a large private health care system in the United States. Lee, SW., Werner, B., Holt, J., et al.[2023]

The North American Clinical Trials Network (NACTN) has successfully organized a consortium of 10 neurosurgery departments to conduct clinical trials focused on spinal cord injury (SCI), ensuring patient safety and meaningful data outcomes.

NACTN has enrolled 485 patients in a database tracking recovery after SCI and completed the enrollment of 36 patients in its first Phase I clinical trial testing the neuroprotective drug riluzole, which includes pharmacokinetic and pharmacodynamic studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

North American Clinical Trials Network for the Treatment of Spinal Cord Injury: goals and progress. Grossman, RG., Toups, EG., Frankowski, RF., et al.[2013]

The average length of stay in acute rehabilitation for patients with traumatic spinal cord injury decreased from 74 days to 60 days between 1990 and 1997, indicating improvements in rehabilitation efficiency.

However, there was an increase in discharges to nursing homes and rehospitalizations during the same period, suggesting that while rehabilitation may be quicker, some patients still face significant challenges in their recovery and reintegration into the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical rehabilitation length of stay and outcomes for persons with traumatic spinal cord injury--1990-1997. Eastwood, EA., Hagglund, KJ., Ragnarsson, KT., et al.[2022]

The PTEN inhibitor bisperoxovanadium (bpV) significantly reduces cell death in spinal cord injury models, demonstrating its potential for neuroprotection and functional recovery, as shown in both in vitro and in vivo studies.

bpV activates the PI3K/Akt signaling pathway, which is crucial for neuronal survival, and its effects can be blocked by specific inhibitors, indicating a targeted mechanism of action in promoting cell survival after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bisperoxovanadium Mediates Neuronal Protection through Inhibition of PTEN and Activation of PI3K/AKT-mTOR Signaling after Traumatic Spinal Injuries. Walker, CL., Wu, X., Liu, NK., et al.[2021]

The North American Clinical Trials Network (NACTN) has collected high-quality data from over 1000 patients with traumatic spinal cord injury (SCI), enhancing our understanding of SCI management and outcomes.

In a Phase III study of Riluzole involving 192 patients, while the primary efficacy endpoint was not met, significant functional recovery was observed in cervical SCI patients, suggesting potential benefits of Riluzole in specific subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Introduction to the North American Clinical Trials Network for Spinal Cord Injury Special Edition: Reflections on Accomplishments and a Look to the Future. Fehlings, MG., Neal, CJ., Hejrati, N., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical characteristics, hospital course, and disposition of patients with nontraumatic spinal cord injury in a large private health care system in the United States. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

North American Clinical Trials Network for the Treatment of Spinal Cord Injury: goals and progress. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Medical rehabilitation length of stay and outcomes for persons with traumatic spinal cord injury--1990-1997. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Bisperoxovanadium Mediates Neuronal Protection through Inhibition of PTEN and Activation of PI3K/AKT-mTOR Signaling after Traumatic Spinal Injuries. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

An Introduction to the North American Clinical Trials Network for Spinal Cord Injury Special Edition: Reflections on Accomplishments and a Look to the Future. [2023]