Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2
ConditionLumbosacral Radicular Pain
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSemnur Pharmaceuticals, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
Age 18 to 75 years (inclusive) at the Screening Visit.
A diagnosis of lumbosacral radicular pain (sciatica) present for at least 6 weeks and not more than 9 months prior to the Screening Visit.
Clinical symptoms consistent with the imaging (MRI)
Disqualifiers
Has a body mass index ≥40 kg/m2.
Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
Has been diagnosed with insulin dependent diabetes mellitus.
Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
Trial design
Design model
Parallel
Treatments tested in this trial
SP-102
DrugOne Injection
Placebo
DrugOne injection
Dexamethasone Sodium Phosphate 10 MG/ML
DrugOne injection
Treatment groups
755 Participants
are divided into 3 treatment groupsGroup A: SP-102Experimental treatment 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention
Group C: dexamethasone sodium phosphateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 4Secondary outcomes
1
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 42
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 43
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 44
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 4Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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