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 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 is expected to begin in late 2020 or early 2021.
Who qualifies for this study?
- To participate in this study, you must meet the following criteria:
- 18 – 65 years old
- Traumatic SCI that occurred >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)
All available participant slots at Shepherd Center for Part 1 have been filled, but we are currently collecting information on individuals who may be interested in participating in Part 2 of the study. If you feel like you may qualify and would be interested in learning more, please complete the following intake form. You will be contacted by study staff if you meet criteria.