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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
| Scilex Pharmaceuticals, Inc. | INDUSTRY |
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This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-102 | Experimental | SP-102 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP-102 | Drug | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Weeks |
| 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 | 12 Weeks |
| 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 | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dmitri Lissin, MD | Scilex Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semnur Research Site 1 | Boise | Idaho | 83713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33981160 | Result | Radnovich R, Heinz J, Ambrose C, Stannard E, Lissin D. Repeat Epidural Injections of SP-102 (Dexamethasone Sodium Phosphate Injectable Gel) in Subjects with Lumbosacral Radiculopathy. J Pain Res. 2021 May 5;14:1231-1239. doi: 10.2147/JPR.S303282. eCollection 2021. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SP-102 | SP-102 SP-102: Injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SP-102 | SP-102 SP-102: Injection |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | nmol/L | 12 Weeks |
|
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SP-102 | SP-102 SP-102: Injection | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director Clinical Operations | Scilex Pharmaceuticals, Inc. | 6503866709 | cambrose@scilexpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2018 | Nov 30, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2019 | Nov 30, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| 12 weeks |
| 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. | 12 weeks |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Incidence of treatment-emergent AEs (TEAEs) related to study drug. | 12 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Participants |
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| 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 | 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. | Posted | Mean | Standard Deviation | nmol/L | 12 Weeks |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | cell count × 10^9/L | 12 Weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | Incidence of treatment-emergent AEs (TEAEs) related to study drug. | 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. | Posted | Number | events | 12 weeks |
|
|
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| 19 |
| 0 |
| 19 |
| 13 |
| 19 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | Systematic Assessment |
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| Gastrooesophageal refluxdisease | Gastrointestinal disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Tooth abscess | Infections and infestations | Systematic Assessment |
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| Blood glucose increased | Investigations | Systematic Assessment |
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| White blood cell count increased | Investigations | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
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The Sponsor has the right to first publication of the results of the study. Following the first publication, PIs may publish study data or results; however, the proposed publication must be submitted to the Sponsor for review and approval in writing at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study Data.
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
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