Phase 3 Spinal Cord Injury Trial Began Dosing
The RESTORE study is evaluating a new injectable drug for adults with chronic cervical spinal cord injuries.
Updated on Oct. 12, 2026 in Stroke
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NervGen has officially begun dosing participants in the Phase 3 RESTORE study, a trial investigating the safety and efficacy of the investigational drug NVG-291. The study seeks to enroll approximately 150 adults in the United States and Canada living with chronic motor-incomplete spinal cord injuries.
Why it matters
This trial represents a significant step in determining if NVG-291 can improve functional outcomes, specifically hand dexterity, for individuals up to ten years post-injury. The research follows functional improvements documented in the earlier CONNECT SCI study.
The RESTORE study utilizes a randomized, double-blind, placebo-controlled design to track improvement in hand function among 150 adults. Participants receive daily subcutaneous injections of either NVG-291 or a placebo for 12 weeks, followed by a four-week observation period.
The players
NervGen
A biotechnology company focused on developing therapies for nerve repair and spinal cord injury.
FDA
The United States agency responsible for regulating pharmaceuticals and granting Fast Track designation to expedite drug development.
European Medicines Agency
The regulatory body that oversees medicine evaluation and granted Orphan Drug designation for this study.
The details
The trial targets adults with motor-incomplete cervical spinal cord injuries at a level of C7 or higher. Participants receive a daily subcutaneous injection of NVG-291 or a placebo for a 12-week period. The primary endpoint evaluates success through the GRASSP Quantitative Prehension scale, which measures changes in hand function and grasp capability throughout the study duration.
Timeline
October 12, 2026: The first participant was successfully dosed in the RESTORE study.
Second half of 2027: NervGen anticipates reaching full enrollment for the trial.
First half of 2028: The company expects to report the initial topline study data.
Health Landscape
This research builds directly upon the functional improvements observed in the preliminary CONNECT SCI study. The trial is positioned to determine if the therapeutic approach can deliver meaningful neurological recovery in the established standard of care for chronic spinal cord injury.
Patients living with chronic cervical motor-incomplete spinal cord injuries may consider discussing trial criteria with their neurologists to see if they fit the specific eligibility requirements. Any decision regarding experimental treatment participation should be made after a conversation with a physician.
The takeaway
The initiation of this Phase 3 trial is a notable development for those tracking potential therapies for chronic spinal cord injury. Individuals interested in the study can review the criteria on the official site to discuss potential eligibility with their clinical care team.
What happens next
NervGen expects to reach full enrollment by the second half of 2027, with topline data reporting anticipated in the first half of 2028.
Further reading
Learn more about the latest innovations and ongoing research in neurological recovery on our Stroke page.
More information
You can find comprehensive details regarding the study design and current participation criteria on the clinical study information and eligibility lookup portal.
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Should clinical trials for spinal cord injuries prioritize functional recovery improvements over other treatment outcomes?
