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.
Provide written informed consent prior to any study-specific procedures.
Be 18 to 75 years of age, inclusive.
Have chronic cervical spinal cord injury resulting from acute traumatic injury occurring 1 to 10 years prior to randomization.
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.
Nontraumatic spinal cord injury, penetrating spinal cord injury, multiple noncontiguous spinal cord lesions, or anatomically complete spinal cord transection.
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.
Any condition preventing adequate assessment of all four extremities.
Any neurological condition that could interfere with study assessments or interpretation of results, including multiple sclerosis, stroke, amyotrophic lateral sclerosis, dementia, or progressive syringomyelia.
Parallel
NVG-291
DrugNVG-291 is an investigational peptide therapeutic administered by subcutaneous injection. Participants randomized to the experimental arm will receive NVG-291 once daily for 12 weeks. NVG-291 is designed to promote nervous system repair and functional recovery following chronic spinal cord injury.
Placebo
DrugMatching placebo is supplied as a sterile lyophilized formulation matching NVG-291 in appearance and route of administration. Participants randomized to the placebo arm will receive placebo once daily by subcutaneous injection for 12 weeks.
Efficacy of NVG-291 as measured by change from baseline in combined Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension (QtP) score
Change from baseline to Week 12 in the combined GRASSP QtP score. The combined GRASSP QtP score is the sum of four Prehension Performance task scores for the right and the left hand and ranges from 0 to 40. A higher score on GRASSP QtP indicates improved prehension performance.
Efficacy of NVG-291 as measured by change at Week 12 in Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) at Week 12. The PGIC is a single-item, patient-reported measure of perception of change in condition, scored on a 7-point scale from 1 (very much worse) to 7 (very much improved). Higher scores indicate greater improvement.
Efficacy of NVG-291 as measured by change at Week 12 in Clinician Global Impression of Change (CGIC)
The CGIC is a single-item, clinician-reported measure of change in condition, scored on a 7-point scale from 1 (very much worse) to 7 (very much improved). Higher scores indicate greater improvement.
Efficacy of NVG-291 as measured by change from baseline in Spinal Cord Independence Measure Version III (SCIM-III)
Change from baseline to Week 12 in the Spinal Cord Independence Measure, Version III (SCIM-III) total score. The SCIM-III total score ranges from 0 to 100. Higher scores indicate greater functional independence.
Efficacy of NVG-291 as measured by change from baseline in Modified Ashworth Scale (MAS) score
Change from baseline to Week 12 in the Modified Ashworth Scale (MAS) total score, the sum of scores for the quadriceps femoris, hamstrings, and soleus assessed bilaterally. Total scores range from 0 to 30. Higher scores indicate more severe spasticity.
Efficacy of NVG-291 as measured by change from baseline in combined GRASSP Quantitative Prehension (QtP) score at Week 16
Change from baseline to Week 16 in the combined GRASSP QtP score. The combined GRASSP QtP score is the sum of four Prehension Performance task scores for the right and the left hand and ranges from 0 to 40. A higher score on GRASSP QtP indicates improved prehension performance.
Efficacy of NVG-291 as measured by change from baseline in combined GRASSP Total Score at Week 16
Change from baseline to Week 16 in the combined GRASSP Total score, the sum of the strength, sensibility, and prehension domain scores for the right and the left hand. The combined GRASSP Total score ranges from 0 to 188. Higher scores indicate better upper-extremity function.
Efficacy of NVG-291 as measured by change from baseline in SCI-QOL Bladder Management Short Form score
Change from baseline to Week 12 in the Spinal Cord Injury - Quality of Life (SCI-QOL) Bladder Management Difficulties Short Form score. Scores are reported as T-scores calibrated to the SCI reference population (mean 50, standard deviation 10), with a possible range of 40.9 to 81.6 for this short form. Higher scores indicate greater bladder management difficulties.
Efficacy of NVG-291 as measured by change from baseline in EQ-5D-5L score
Change from baseline to Week 12 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, reported as the EQ Visual Analogue Scale (EQ VAS) score. The EQ VAS records self-rated health on a scale of 0 to 100, where 0 is the worst imaginable health state and 100 is the best imaginable health state. Higher scores indicate better health.
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