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

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.

Time frame: Week 12

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.

Time frame: Week 12

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.

Time frame: Baseline to Week 12

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.

Time frame: Baseline to Week 12

Participant-perceived meaningfulness of change assessed by the patient-reported outcome (PRO) Qualitative Interview

Patient-reported perception of change from baseline at Week 12, assessed by a semi-structured qualitative interview conducted within 14 days after the Week 12 visit. The interview is not a scored scale and has no minimum or maximum value. Transcripts are coded against a prespecified analysis framework, and results will be reported as the number and percentage of participants reporting meaningful improvement in each prespecified concept.

Time frame: Within 14 days after the Week 12 visit

Efficacy of NVG-291 as measured by change from baseline in 10 Meter Walk Test (10mWT)

Change from baseline to Week 12 in walking velocity (meters/second) measured by the 10 Meter Walk Test (10mWT). Higher walking velocity indicates better performance.

Time frame: Baseline to Week 12

Efficacy of NVG-291 as measured by change from baseline in combined GRASSP Total Score

Change from baseline to Week 12 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.

Time frame: Baseline to Week 12

Efficacy of NVG-291 as measured by change from baseline in Clinician Global Impression of Severity (CGIS)

Change from baseline to Week 12 in the Clinician Global Impression of Severity (CGIS) score. The CGIS is a single-item, clinician-rated measure of overall severity, scored on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity.

Time frame: Baseline to Week 12

Efficacy of NVG-291 as measured by change from baseline in Patient Global Impression of Severity (PGIS)

Change from baseline to Week 12 in the Patient Global Impression of Severity (PGIS) score. The PGIS is a single-item, participant-rated measure of overall severity, scored on a 5-point scale from 1 (none) to 5 (very severe). Higher scores indicate greater severity.

Time frame: Baseline to Week 12

Safety and tolerability of NVG-291 as assessed by the incidence of adverse events (AEs)

Incidence of AEs.

Time frame: Informed consent through Week 16

Safety and tolerability of NVG-291 as assessed by the incidence of serious adverse events (SAEs)

Incidence of SAEs.

Time frame: Informed consent through Week 16

Safety and tolerability of NVG-291 as assessed by the number of participants with clinically significant laboratory abnormalities

Number of participants with clinically significant abnormalities in clinical laboratory assessments.

Time frame: Baseline through Week 16

Safety and tolerability of NVG-291 as assessed by change from baseline in systolic blood pressure

Change from baseline in systolic blood pressure (mmHg).

Time frame: Baseline through Week 16

Safety and tolerability of NVG-291 as assessed by change from baseline in diastolic blood pressure

Change from baseline in diastolic blood pressure (mmHg).

Time frame: Baseline through Week 16

Safety and tolerability of NVG-291 as assessed by change from baseline in heart rate

Change from baseline in heart rate (beats/minute).

Time frame: Baseline through Week 16

Safety and tolerability of NVG-291 as assessed by change from screening in body weight

Change from screening in body weight (kg).

Time frame: Screening through Week 16

Safety and tolerability of NVG-291 as assessed by change from baseline in body temperature

Change from baseline in body temperature (°C).

Time frame: Baseline through Week 16

Safety and tolerability of NVG-291 as assessed by the number of participants with clinically significant electrocardiogram abnormalities

Number of participants with clinically significant electrocardiogram (ECG) abnormalities.

Time frame: Baseline through Week 16

Pharmacokinetics of NVG-291 as measured by plasma NVG-291 concentration

Plasma NVG-291 concentration (ng/mL) in participants randomized to NVG-291 who are included in the pharmacokinetic subset. Samples are collected pre-dose, 30 minutes post-dose, and 3 hours post-dose at each specified visit, to support a population pharmacokinetic (PopPK) analysis.

Time frame: Day 1 Through Week 12