- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613662
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
An Open-label, Single-arm Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects With Lumbosacral Radiculopathy
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Idaho
-
Boise, Idaho, United States, 83713
- Semnur Research Site 1
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SP-102
|
Injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plasma Cortisol Concentrations From Baseline
Time Frame: 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 |
12 Weeks
|
Change in Blood Glucose Levels From Baseline
Time Frame: 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 |
12 Weeks
|
Change in White Blood Cell (WBC) Levels From Baseline
Time Frame: 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 |
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
Time Frame: 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.
|
12 weeks
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
Time Frame: 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.
|
12 weeks
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 12 weeks
|
Incidence of treatment-emergent AEs (TEAEs) related to study drug.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SP-102-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lumbosacral Radicular Pain
-
Yonsei UniversityTerminatedLumbosacral Radicular PainKorea, Republic of
-
Yonsei UniversityCompletedLumbosacral Radicular PainKorea, Republic of
-
Yonsei UniversityCompletedLumbosacral Radicular PainKorea, Republic of
-
Uppsala UniversityBoston Children's Hospital; Linkoeping UniversityUnknownLow Back Pain | Pain, Intractable | Radicular; Neuropathic, Lumbar, Lumbosacral | FBSSSweden
-
Scilex Pharmaceuticals, Inc.Worldwide Clinical Trials; Semnur Pharmaceuticals, Inc.Completed
-
Sheba Medical CenterUnknownLow Back Pain | Radicular; Neuropathic, Lumbar, Lumbosacral | Back Pain With Radiation
-
Ahadian, Farshad M., M.D.San Diego Veterans Healthcare SystemCompletedRadicular; Neuropathic, Lumbar, LumbosacralUnited States
-
Emory UniversityCompletedRadicular; Neuropathic, Lumbar, Lumbosacral | Radicular; Neuropathic, CervicalUnited States
-
Federico II UniversityNot yet recruitingPain, Chronic | Lumbosacral Radiculopathy | Radicular; Neuropathic
-
Duke UniversityForest LaboratoriesCompletedRadicular Pain Related to Lumbosacral Disc Disease
Clinical Trials on SP-102
-
Scilex Pharmaceuticals, Inc.Worldwide Clinical Trials; Semnur Pharmaceuticals, Inc.Completed
-
Fotona d.o.o.UnknownStress Urinary IncontinenceCanada
-
L&C BioPROMeDisRecruitingHerniation, DiscKorea, Republic of
-
Ruijin HospitalRecruiting
-
Neothetics, IncCompleted
-
JhpiegoBarcelona Institute for Global HealthCompletedMalaria in PregnancyCongo, The Democratic Republic of the, Madagascar, Mozambique, Nigeria
-
Salarius Pharmaceuticals, LLCNot yet recruitingLymphoma, Non-Hodgkin's, Adult
-
Morris Innovative IncorporatedDeborah Heart and Lung CenterUnknownVascular DiseasesUnited States
-
Pharmacosmos A/SICON plcRecruitingBeta Thalassemia Major AnemiaDenmark
-
Shin Poong Pharmaceutical Co. Ltd.CompletedStroke | Acute Coronary SyndromeUnited Kingdom