RESET Trial: Two-Part Chronic SCI Study
ReNetX Safety, Efficacy and Tolerability of AXER-204 for Chronic SCI
AXER-204 was found to help promote nerve growth and possible neurological recovery in animal laboratory studies using rats and monkeys. While a single dose is not expected to promote neurological recovery in humans, this study will confirm its safety and tolerability. A follow up study will test the potential effects of repeated doses.
This is the first clinical study to date being conducted in humans with AXER-204.
Part 1 of the trial is a multicenter, open-label, single ascending dose study in participants with chronic cervical spinal cord injury. The purpose of Part 1 is to determine if a single dose of an investigational drug, AXER-204, can be safely injected into the spinal canal and tolerated by people with chronic spinal cord injury (SCI). Four cohorts of 6 participants each are planned, with participants within each cohort expected to receive the same dose of AXER-204.
Part 1 concluded in Summer of 2020.
Part 2 is a multicenter, randomized, double-blind, placebo-controlled, repeat dose study in chronic cervical spinal cord injury participants. The purpose of Part 2 is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204 compared to placebo. Up to 42 participants will be randomized (ratio 1:1) to receive repeated doses of AXER-204 or placebo (a phosphate buffered saline formulation). The dose level and dose frequency will be dependent upon outcomes from Part 1.
Part 2 participants are currently in long term follow up; recruitment is closed.
Who qualifies for this study?
- To participate in this study, you must meet the following criteria:
- 18 – 65 years old
- Traumatic SCI that occurred greater than 1 year ago
- Cervical SCI with weakness in the arms and/or hands
- In excellent overall health
- If any of the following apply to you, you are not eligible to participate:
- History of a stroke, brain injury, or any other chronic medical condition
- Implanted baclofen or pain pump
- Require any assistance to breathe (i.e. mechanical ventilation)
- Recent medication changes
- Penetrating Injury (i.e. Gunshot/stabbing)