Clinical Trial Search

Primary: Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale…

Primary: Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg — -2.34; -1.16 Change in score on a scale…

Primary: Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad) — 58.7; 67.7; 13.6; 59.7 units on a scale

Primary: Pain Scores (NRS) at 3-weeks — 6; 3 units on a scale — p=0.279

Primary: Pain Assessed by Visual Analogue Scale — 5.63; 5.92 units on a scale

Primary: Numerical Rating Leg Pain Score — 2.54; 3.56; 3.78 units on a scale

Primary: Visual Analog Scale — 5.638; 5.050; 5.094; 4.894 Centimeters

Primary: Recruitment Rate — 32 Participants

Primary: The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline — -4.3; -3.0 score on a scale

Primary: Time to First Symptoms of Moderate Pain — 2.52; 3.06 minutes

Primary: Numeric Pain Rating Score — 7.9; 8.1; 4.9; 3.4 units on a scale — p=<0.001

Primary: VAS for Lumbar Pain in 3 Months — 2.63; 4.53 units on a scale — p=0.05

Primary: The Number of Participants With Adverse Events by Dose (Part A) — 1; 1; 2; 2 participants

Primary: Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain — 60; 72 percentage of participants — p=0.23

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAE) — 615 Participants

Primary: Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) — 3.1; 2.9; -1.306; -0.357 scores on a scale — p=<0.001

Primary: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale — 3.3; 3.7 units on a scale

Primary: Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable — 7.1; 5.8 units on a scale

Primary: Roland Morris — 11.8; 12.5 units on a scale

Primary: Clinical Pain Severity - 50% Reduction Responders vs Nonresponders — -83; 0 percentage of change

Primary: Numeric Pain Rating Scale (NPRS) — 14; 3 Participants

Primary: Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days — -41.7; -34.2 units on a scale — p=0.0263

Primary: Quebec Back Pain Disability Scale — 27.9; 27.9; 16.7; 20.3 score on a scale

Primary: Effect Size of VAS Pain — 24.8; 31.3 units on a scale

Primary: Change in McGill Pain Questionnaire - Short Form — -0.73; -3.78 units on a scale

Primary: Swiss Spinal Stenosis (SSS) Questionnaire Score — -2.0; -1.7; -4.1 units on a scale — p=0.73

Primary: Pain Diary — 6.71; 5 units on a scale

Primary: Neurological Assessment for Motor Function and Reflexes/Sensory — 0; 0 participants

Primary: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.3 units on a scale

Primary: Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs — 6; 6; 6; 5 Participants