RecruitingChronic Spinal Cord Injury

A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury

Eligible age

18–75 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

The goal of this clinical trial is to learn if NVG-291 can improve function in adults with chronic cervical motor-incomplete spinal cord injury. It will also learn about the safety of NVG-291. The main questions it aims to answer are: * Does NVG-291 improve hand function and daily activities? * What side effects do participants have when taking NVG-291? Researchers will compare NVG-291 to a placebo (a look-alike substance that does not contain NVG-291) to see if NVG-291 improves function in adults with chronic cervical motor-incomplete spinal cord injury. Participants will: * Take NVG-291 or a placebo by injection under the skin (subcutaneous) once daily for 12 weeks. * Attend clinic visits for checkups and safety tests. * Complete tests and questionnaires about hand function, walking, daily activities, and quality of life. * Take part in an interview about changes in their condition, within 14 days after the Week 12 visit.

Sponsor: NervGen Pharma

You may qualify if…

✓ 1. Provide written informed consent prior to any study-specific procedures.
✓ 2. Be 18 to 75 years of age, inclusive.
✓ 3. Have chronic cervical spinal cord injury resulting from acute traumatic injury occurring 1 to 10 years prior to randomization.
✓ 4. Have motor-incomplete cervical spinal cord injury as determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) assessment at screening, meeting all of the following: American Spinal Injury Association (ASIA) Impairment Scale grade C or D; motor level at C7 or rostral on both the right and the left side; and a muscle grade of 1 or greater on ISNCSCI manual muscle testing in at least one lower-extremity key muscle function (L2 to S1) on either side.
✓ 5. Have documented traumatic spinal cord injury confirmed by historical and/or current magnetic resonance imaging (MRI) or computed tomography (CT).
✓ 6. Have a Walking Index for Spinal Cord Injury II (WISCI II) score of 0 to 14, inclusive.
✓ 7. Have a score of at least 2 on at least one GRASSP Prehension Ability grasp pattern (cylindrical grasp, lateral key pinch, or tip-to-tip pinch) in at least one upper extremity, no more than one grasp-pattern score of 4 in the qualifying upper extremity, and a combined (bilateral) GRASSP Quantitative Prehension score no greater than 34, of a possible 40, across the sum of the four Prehension Performance task scores for the right and left hand.
✓ 8. Be willing and able to comply with study visits, assessments, study procedures, and study drug administration requirements.

You may not qualify if…

✕ 1. Nontraumatic spinal cord injury, penetrating spinal cord injury, multiple noncontiguous spinal cord lesions, or anatomically complete spinal cord transection.
✕ 2. Ventilatory dependence, defined as invasive mechanical ventilation via tracheostomy, noninvasive ventilation for chronic respiratory failure, or diaphragmatic or phrenic nerve pacing. Continuous or automatic positive airway pressure (CPAP/APAP) used solely for obstructive sleep apnea is not exclusionary.
✕ 3. Any condition preventing adequate assessment of all four extremities.
✕ 4. Any neurological condition that could interfere with study assessments or interpretation of results, including multiple sclerosis, stroke, amyotrophic lateral sclerosis, dementia, or progressive syringomyelia.
✕ 5. History of uncontrolled seizures or any seizure within 6 months prior to screening.
✕ 6. Pregnant or breastfeeding.
✕ 7. History of substance abuse within 12 months prior to screening.
✕ 8. Evidence of spinal instability, persistent spinal stenosis, or spinal cord compression related to the original injury.