Lumbosacral Radicular Pain
Conditions
Keywords
lumbosacral radicular pain, sciatica, leg pain
Brief summary
This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.
Interventions
DRUGSP-102
Injection
Sponsors
Worldwide Clinical Trials
Scilex Pharmaceuticals, Inc.
Semnur Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * 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 70 years (inclusive) at the Screening Visit. * A diagnosis of lumbosacral radicular pain (sciatica). * Agrees to follow study-specific medication requirements. * If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study. * Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures. Main
Exclusion criteria
* Has radiologic evidence of a condition that would compromise study outcomes. * 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. * Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study. * Has a body mass index ≥40 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Cortisol Concentrations From Baseline | 12 Weeks | Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks |
| Change in Blood Glucose Levels From Baseline | 12 Weeks | Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks |
| Change in White Blood Cell (WBC) Levels From Baseline | 12 Weeks | Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | 12 weeks | The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented. |
| Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | 12 weeks | The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | 12 weeks | Incidence of treatment-emergent AEs (TEAEs) related to study drug. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SP-102 SP-102
SP-102: Injection | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | SP-102 |
|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 14.42 |
| BMI | 30.51 kg/m^2 STANDARD_DEVIATION 6.127 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 166.51 cm STANDARD_DEVIATION 12.294 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
| Weight | 84.03 kg STANDARD_DEVIATION 16.412 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 13 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Change in Blood Glucose Levels From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Time frame: 12 Weeks
Population: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SP-102 | Change in Blood Glucose Levels From Baseline | T1: Day 1 (predose) | 4.993 nmol/L | Standard Deviation 0.5216 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T1: Day 2 | 6.155 nmol/L | Standard Deviation 0.9009 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T1: Day 3 | 4.528 nmol/L | Standard Deviation 0.4451 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T1: Day 4 | 4.676 nmol/L | Standard Deviation 0.5509 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T1: Day 5 | 4.958 nmol/L | Standard Deviation 0.4362 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T1: Day 8 | 5.059 nmol/L | Standard Deviation 0.6597 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T1: Day 15 | 5.254 nmol/L | Standard Deviation 0.8143 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T1: Day 28 | 4.963 nmol/L | Standard Deviation 0.7116 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T2: Day 1 (predose) | 4.867 nmol/L | Standard Deviation 0.5655 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T2: Day 2 | 5.865 nmol/L | Standard Deviation 0.8673 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T2: Day 3 | 4.581 nmol/L | Standard Deviation 0.4986 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T2: Day 4 | 4.850 nmol/L | Standard Deviation 0.8078 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T2: Day 5 | 4.959 nmol/L | Standard Deviation 0.5791 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T2: Day 8 | 4.821 nmol/L | Standard Deviation 0.4463 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T2: Day 15 | 5.237 nmol/L | Standard Deviation 0.8394 |
| SP-102 | Change in Blood Glucose Levels From Baseline | T2: Day 28 | 4.945 nmol/L | Standard Deviation 0.5959 |
Primary
Change in Plasma Cortisol Concentrations From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Time frame: 12 Weeks
Population: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T1: Day 1 (predose) | 36.62 nmol/L | Standard Deviation 31.81 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T1: Day 2 | 0.64 nmol/L | Standard Deviation 0.27 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T1: Day 3 | 6.26 nmol/L | Standard Deviation 9 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T1: Day 4 | 29.77 nmol/L | Standard Deviation 2.6 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T1: Day 5 | 39.91 nmol/L | Standard Deviation 40.53 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T1: Day 8 | 39.71 nmol/L | Standard Deviation 28.97 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T1: Day 15 | 44.28 nmol/L | Standard Deviation 33.55 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T1: Day 28 | 25.08 nmol/L | Standard Deviation 21.34 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T2: Day 1 (predose) | 38.81 nmol/L | Standard Deviation 41.1 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T2: Day 2 | 0.64 nmol/L | Standard Deviation 0.23 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T2: Day 3 | 3.68 nmol/L | Standard Deviation 3.85 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T2: Day 4 | 50.71 nmol/L | Standard Deviation 56.21 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T2: Day 5 | 38.35 nmol/L | Standard Deviation 35 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T2: Day 8 | 41.73 nmol/L | Standard Deviation 38.95 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T2: Day 15 | 73.31 nmol/L | Standard Deviation 97.64 |
| SP-102 | Change in Plasma Cortisol Concentrations From Baseline | T2: Day 28 | 28.18 nmol/L | Standard Deviation 20.34 |
Primary
Change in White Blood Cell (WBC) Levels From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Time frame: 12 Weeks
Population: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T1: Day 1 (predose) | 6.65 cell count × 10^9/L | Standard Deviation 2.051 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T1: Day 2 | 13.43 cell count × 10^9/L | Standard Deviation 3.726 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T1: Day 3 | 9.33 cell count × 10^9/L | Standard Deviation 2.336 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T1: Day 4 | 7.38 cell count × 10^9/L | Standard Deviation 1.863 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T1: Day 5 | 6.81 cell count × 10^9/L | Standard Deviation 1.771 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T1: Day 8 | 6.91 cell count × 10^9/L | Standard Deviation 2.212 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T1: Day 15 | 7.26 cell count × 10^9/L | Standard Deviation 1.873 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T1: Day 28 | 6.15 cell count × 10^9/L | Standard Deviation 1.339 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T2: Day 1 (predose) | 6.77 cell count × 10^9/L | Standard Deviation 1.865 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T2: Day 2 | 13.43 cell count × 10^9/L | Standard Deviation 4.517 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T2: Day 3 | 9.21 cell count × 10^9/L | Standard Deviation 3.199 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T2: Day 4 | 7.88 cell count × 10^9/L | Standard Deviation 2.302 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T2: Day 5 | 7.28 cell count × 10^9/L | Standard Deviation 2.087 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T2: Day 8 | 7.31 cell count × 10^9/L | Standard Deviation 2.803 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T2: Day 15 | 8.05 cell count × 10^9/L | Standard Deviation 3.592 |
| SP-102 | Change in White Blood Cell (WBC) Levels From Baseline | T2: Day 28 | 6.07 cell count × 10^9/L | Standard Deviation 1.541 |
Secondary
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented.
Time frame: 12 weeks
Population: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Baseline (pre-dose) | 5.2 score on a scale | Standard Deviation 1.46 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Day 1 | 5.2 score on a scale | Standard Deviation 1.5 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Day 2 | 3.5 score on a scale | Standard Deviation 2.14 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Day 3 | 2.3 score on a scale | Standard Deviation 1.45 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Day 4 | 2.7 score on a scale | Standard Deviation 2.11 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Day 5 | 2.6 score on a scale | Standard Deviation 2.39 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Day 8 | 2.8 score on a scale | Standard Deviation 2.48 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Day 15 | 3.2 score on a scale | Standard Deviation 2.46 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T1: Day 28 | 3.9 score on a scale | Standard Deviation 1.9 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Baseline (pre-dose) | 5.4 score on a scale | Standard Deviation 1.35 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Day 1 | 5.3 score on a scale | Standard Deviation 1.35 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Day 2 | 3.5 score on a scale | Standard Deviation 2.33 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Day 3 | 2.1 score on a scale | Standard Deviation 1.55 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Day 4 | 2.8 score on a scale | Standard Deviation 1.81 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Day 5 | 2.3 score on a scale | Standard Deviation 1.35 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Day 8 | 2.4 score on a scale | Standard Deviation 2.03 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Day 15 | 2.9 score on a scale | Standard Deviation 1.96 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | T2: Day 28 | 3.2 score on a scale | Standard Deviation 2.27 |
Secondary
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented.
Time frame: 12 weeks
Population: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Baseline (pre-dose) | 5.4 score on a scale | Standard Deviation 1.3 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Day 1 | 5.3 score on a scale | Standard Deviation 1.29 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Day 2 | 3.2 score on a scale | Standard Deviation 1.84 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Day 3 | 2.2 score on a scale | Standard Deviation 1.61 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Day 4 | 2.5 score on a scale | Standard Deviation 2.14 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Day 5 | 2.3 score on a scale | Standard Deviation 2.21 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Day 8 | 2.5 score on a scale | Standard Deviation 2.37 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Day 15 | 3.2 score on a scale | Standard Deviation 2.48 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T1: Day 28 | 3.4 score on a scale | Standard Deviation 1.8 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Baseline (pre-dose) | 5.4 score on a scale | Standard Deviation 1.18 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Day 1 | 5.2 score on a scale | Standard Deviation 1.32 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Day 2 | 3.5 score on a scale | Standard Deviation 2.36 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Day 3 | 1.9 score on a scale | Standard Deviation 1.28 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Day 4 | 2.1 score on a scale | Standard Deviation 1.58 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Day 5 | 1.9 score on a scale | Standard Deviation 1.53 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Day 8 | 2.2 score on a scale | Standard Deviation 2.21 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Day 15 | 2.4 score on a scale | Standard Deviation 2.21 |
| SP-102 | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | T2: Day 28 | 2.9 score on a scale | Standard Deviation 2.46 |
Secondary
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence of treatment-emergent AEs (TEAEs) related to study drug.
Time frame: 12 weeks
Population: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SP-102 | Incidence of Treatment-Emergent Adverse Events (TEAEs) | Treatment 1 | 20 events |
| SP-102 | Incidence of Treatment-Emergent Adverse Events (TEAEs) | Treatment 2 | 10 events |