A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: SP-102 SP-102 |
Drug: SP-102
Injection
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Semnur Research Site 1 | Boise | Idaho | United States | 83713 |
Sponsors and Collaborators
- Semnur Pharmaceuticals, Inc.
- Worldwide Clinical Trials
- Scilex Pharmaceuticals, Inc.
Investigators
- Study Director: Dmitri Lissin, MD, Scilex Pharmaceuticals, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.- SP-102-03
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | SP-102 |
---|---|
Arm/Group Description | SP-102 SP-102: Injection |
Period Title: Overall Study | |
STARTED | 19 |
COMPLETED | 19 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | SP-102 |
---|---|
Arm/Group Description | SP-102 SP-102: Injection |
Overall Participants | 19 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
54.8
(14.42)
|
Sex: Female, Male (Count of Participants) | |
Female |
12
63.2%
|
Male |
7
36.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
3
15.8%
|
Not Hispanic or Latino |
16
84.2%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
19
100%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Height (cm) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [cm] |
166.51
(12.294)
|
Weight (kg) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [kg] |
84.03
(16.412)
|
BMI (kg/m^2) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [kg/m^2] |
30.51
(6.127)
|
Outcome Measures
Title | Change in Plasma Cortisol Concentrations From Baseline |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SP-102 |
---|---|
Arm/Group Description | SP-102 SP-102: Injection |
Measure Participants | 19 |
T1: Day 1 (predose) |
36.62
(31.81)
|
T1: Day 2 |
0.64
(0.27)
|
T1: Day 3 |
6.26
(9.00)
|
T1: Day 4 |
29.77
(2.60)
|
T1: Day 5 |
39.91
(40.53)
|
T1: Day 8 |
39.71
(28.97)
|
T1: Day 15 |
44.28
(33.55)
|
T1: Day 28 |
25.08
(21.34)
|
T2: Day 1 (predose) |
38.81
(41.10)
|
T2: Day 2 |
0.64
(0.23)
|
T2: Day 3 |
3.68
(3.85)
|
T2: Day 4 |
50.71
(56.21)
|
T2: Day 5 |
38.35
(35.00)
|
T2: Day 8 |
41.73
(38.95)
|
T2: Day 15 |
73.31
(97.64)
|
T2: Day 28 |
28.18
(20.34)
|
Title | Change in Blood Glucose Levels From Baseline |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SP-102 |
---|---|
Arm/Group Description | SP-102 SP-102: Injection |
Measure Participants | 19 |
T1: Day 1 (predose) |
4.993
(0.5216)
|
T1: Day 2 |
6.155
(0.9009)
|
T1: Day 3 |
4.528
(0.4451)
|
T1: Day 4 |
4.676
(0.5509)
|
T1: Day 5 |
4.958
(0.4362)
|
T1: Day 8 |
5.059
(0.6597)
|
T1: Day 15 |
5.254
(0.8143)
|
T1: Day 28 |
4.963
(0.7116)
|
T2: Day 1 (predose) |
4.867
(0.5655)
|
T2: Day 2 |
5.865
(0.8673)
|
T2: Day 3 |
4.581
(0.4986)
|
T2: Day 4 |
4.850
(0.8078)
|
T2: Day 5 |
4.959
(0.5791)
|
T2: Day 8 |
4.821
(0.4463)
|
T2: Day 15 |
5.237
(0.8394)
|
T2: Day 28 |
4.945
(0.5959)
|
Title | Change in White Blood Cell (WBC) Levels From Baseline |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SP-102 |
---|---|
Arm/Group Description | SP-102 SP-102: Injection |
Measure Participants | 19 |
T1: Day 1 (predose) |
6.65
(2.051)
|
T1: Day 2 |
13.43
(3.726)
|
T1: Day 3 |
9.33
(2.336)
|
T1: Day 4 |
7.38
(1.863)
|
T1: Day 5 |
6.81
(1.771)
|
T1: Day 8 |
6.91
(2.212)
|
T1: Day 15 |
7.26
(1.873)
|
T1: Day 28 |
6.15
(1.339)
|
T2: Day 1 (predose) |
6.77
(1.865)
|
T2: Day 2 |
13.43
(4.517)
|
T2: Day 3 |
9.21
(3.199)
|
T2: Day 4 |
7.88
(2.302)
|
T2: Day 5 |
7.28
(2.087)
|
T2: Day 8 |
7.31
(2.803)
|
T2: Day 15 |
8.05
(3.592)
|
T2: Day 28 |
6.07
(1.541)
|
Title | Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SP-102 |
---|---|
Arm/Group Description | SP-102 SP-102: Injection |
Measure Participants | 19 |
T1: Baseline (pre-dose) |
5.4
(1.30)
|
T1: Day 1 |
5.3
(1.29)
|
T1: Day 2 |
3.2
(1.84)
|
T1: Day 3 |
2.2
(1.61)
|
T1: Day 4 |
2.5
(2.14)
|
T1: Day 5 |
2.3
(2.21)
|
T1: Day 8 |
2.5
(2.37)
|
T1: Day 15 |
3.2
(2.48)
|
T1: Day 28 |
3.4
(1.80)
|
T2: Baseline (pre-dose) |
5.4
(1.18)
|
T2: Day 1 |
5.2
(1.32)
|
T2: Day 2 |
3.5
(2.36)
|
T2: Day 3 |
1.9
(1.28)
|
T2: Day 4 |
2.1
(1.58)
|
T2: Day 5 |
1.9
(1.53)
|
T2: Day 8 |
2.2
(2.21)
|
T2: Day 15 |
2.4
(2.21)
|
T2: Day 28 |
2.9
(2.46)
|
Title | Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SP-102 |
---|---|
Arm/Group Description | SP-102 SP-102: Injection |
Measure Participants | 19 |
T1: Baseline (pre-dose) |
5.2
(1.46)
|
T1: Day 1 |
5.2
(1.50)
|
T1: Day 2 |
3.5
(2.14)
|
T1: Day 3 |
2.3
(1.45)
|
T1: Day 4 |
2.7
(2.11)
|
T1: Day 5 |
2.6
(2.39)
|
T1: Day 8 |
2.8
(2.48)
|
T1: Day 15 |
3.2
(2.46)
|
T1: Day 28 |
3.9
(1.90)
|
T2: Baseline (pre-dose) |
5.4
(1.35)
|
T2: Day 1 |
5.3
(1.35)
|
T2: Day 2 |
3.5
(2.33)
|
T2: Day 3 |
2.1
(1.55)
|
T2: Day 4 |
2.8
(1.81)
|
T2: Day 5 |
2.3
(1.35)
|
T2: Day 8 |
2.4
(2.03)
|
T2: Day 15 |
2.9
(1.96)
|
T2: Day 28 |
3.2
(2.27)
|
Title | Incidence of Treatment-Emergent Adverse Events (TEAEs) |
---|---|
Description | Incidence of treatment-emergent AEs (TEAEs) related to study drug. |
Time Frame | 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. |
Arm/Group Title | SP-102 |
---|---|
Arm/Group Description | SP-102 SP-102: Injection |
Measure Participants | 19 |
Treatment 1 |
20
|
Treatment 2 |
10
|
Adverse Events
Time Frame | 12 weeks | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | SP-102 | |
Arm/Group Description | SP-102 SP-102: Injection | |
All Cause Mortality |
||
SP-102 | ||
Affected / at Risk (%) | # Events | |
Total | 0/19 (0%) | |
Serious Adverse Events |
||
SP-102 | ||
Affected / at Risk (%) | # Events | |
Total | 0/19 (0%) | |
Other (Not Including Serious) Adverse Events |
||
SP-102 | ||
Affected / at Risk (%) | # Events | |
Total | 13/19 (68.4%) | |
Gastrointestinal disorders | ||
Abdominal discomfort | 1/19 (5.3%) | |
Abdominal pain | 1/19 (5.3%) | |
Abdominal pain upper | 1/19 (5.3%) | |
Dyspepsia | 2/19 (10.5%) | |
Food poisoning | 1/19 (5.3%) | |
Gastrooesophageal refluxdisease | 1/19 (5.3%) | |
General disorders | ||
Pain | 1/19 (5.3%) | |
Infections and infestations | ||
Bronchitis | 1/19 (5.3%) | |
Nasopharyngitis | 2/19 (10.5%) | |
Respiratory tract infection | 1/19 (5.3%) | |
Tooth abscess | 2/19 (10.5%) | |
Investigations | ||
Blood glucose increased | 1/19 (5.3%) | |
White blood cell count increased | 1/19 (5.3%) | |
Musculoskeletal and connective tissue disorders | ||
Back pain | 1/19 (5.3%) | |
Neck pain | 1/19 (5.3%) | |
Nervous system disorders | ||
Headache | 7/19 (36.8%) | |
Migraine | 1/19 (5.3%) | |
Skin and subcutaneous tissue disorders | ||
Night sweats | 1/19 (5.3%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Associate Director Clinical Operations |
---|---|
Organization | Scilex Pharmaceuticals, Inc. |
Phone | 6503866709 |
cambrose@scilexpharma.com |
- SP-102-03