Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07579351 | Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2 | PHASE3 | NOT YET_RECRUITING | 755 | — | — | Aug 1, 2026 | Jan 1, 2029 | May 12, 2026 | - | — |
| NCT03372161 | Corticosteroid Lumbar Epidural Analgesia for Radiculopathy | PHASE3 | COMPLETED | 401 | — | — | Dec 8, 2017 | Jan 6, 2022 | Sep 19, 2022 | 37 | United States |
| NCT03613662 | A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 | PHASE2 | COMPLETED | 19 | — | — | Jul 13, 2018 | Mar 15, 2019 | Jan 13, 2022 | 1 | United States |
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.
The NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time.
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
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
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
| Arm | Type | Description |
|---|---|---|
| SP-102 | EXPERIMENTAL | - |
| Placebo Comparator | PLACEBO_COMPARATOR | - |
| dexamethasone sodium phosphate | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SP-102 | DRUG | One Injection |
| Placebo | DRUG | One injection |
| Dexamethasone Sodium Phosphate 10 MG/ML | DRUG | One injection |
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 75 years (inclusive) at the Screening Visit. * A diagnosis of lumbosacral r...