This is a research study of SP-102, an experimental medication designed to relieve pain in patients with moderate to severe sciatica (pain in the lower back, hips, buttocks and legs). SP-102, placebo (a medication that looks like SP-102 but does not contain any active ingredient), or an active comparator (dexamethasone sodium phosphate) is given once by the participant's healthcare professional. If a participant meets qualifications, each participant will have the option of receiving one supplemental open-label injection of SP-102, greater than four weeks and up to twenty weeks after their first injection. The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain versus placebo. The study will also measure how well SP-102 relieves pain versus an active comparator medication (dexamethasone sodium phosphate). The study will also investigate the side effects of SP-102.
This is a double-blind, randomized, active comparator (dexamethasone sodium phosphate) and placebo-controlled, multicenter trial in participants with moderate-to-severe lumbosacral radicular pain evaluating the safety and efficacy of a single SP-102 TF injection compared to a single placebo IM injection or a single dexamethasone sodium phosphate TF injection (active comparator), followed by an open-label safety extension, evaluating an optional SP-102 TF injection, if indicated and qualified for, administered once between \> 4 to 20 weeks later.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
755
Mean change from baseline to W4 in the mean NPRS average daily pain score.
The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days \[D-7 to D-1\] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo.
Time frame: Day 1 to week 4
Mean change in ODI total score
The Oswestry disability index (ODI) is a validated, self-reported instrument that evaluates degree of disability (0-100, 0=No disability, 100=Maximum disability). Comparison is between SP-102 and placebo.
Time frame: Day 1 to Week 4
Patient Global Impression of Change
The PGIC scores range from 1 (very much improved) through 7 (very much worse) as assessed by the participant.
Time frame: Day 1 to week 4
Mean change in BPI-Pain Interference (BPI-PI) score from P1 Baseline (D1) to P1 W4 for SP-102 versus placebo.
Participants rate their worst, least, average, and current pain intensity on a 0-10 numeric rating scale as it affects their daily functioning (0=does not interfere and 10=completely interferes).
Time frame: Day 1 to week 4
Proportion of participants with a ≥ 30% improvement from P1 D1 to W4 in mean NPRS average daily pain score in the affected leg for SP-102 versus placebo.
The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days \[D-7 to D-1\] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo.
Time frame: Day 1 to week 4
Proportion of participants with a ≥ 50% improvement from P1 D1 to W4 in mean NPRS average daily pain score in the affected leg for SP-102 versus placebo.
The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days \[D-7 to D-1\] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo.
Time frame: Day 1 to week 4
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