search
Back to results

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

Primary Purpose

Lumbosacral Radicular Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SP-102
Placebo
Sponsored by
Scilex Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbosacral Radicular Pain focused on measuring lumbosacral radicular pain, sciatica, leg pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Semnur Research Site 75
  • Semnur Research Site 52
  • Semnur Research Site 58
  • Semnur Research Site 18
  • Semnur Research Site 47
  • Semnur Research Site 70
  • Semnur Research Site 56
  • Semnur Research Site 81
  • Semnur Research Site 49
  • Semnur Research Site 13
  • Semnur Research Site 61
  • Semnur Research Site 53
  • Semnur Research Site 28
  • Semnur Research Site 64
  • Semnur Research Site 10
  • Semnur Research Site 38
  • Semnur Research Site 40
  • Semnur Research Site 63
  • Semnur Research Site 12
  • Semnur Research Site 19
  • Semnur Reseach Site 62
  • Semnur Research Site 51
  • Semnur Research Site 65
  • Semnur Research Site 60
  • Semnur Research Site 30
  • Semnur Research Site 11
  • Semnur Research Site 20
  • Semnur Research Site 46
  • Semnur Research Site 43
  • Semnur Research Site 36
  • Semnur Research Site 48
  • Semnur Research Site 77
  • Semnur Research Site 15
  • Semnur Research Site 54
  • Semnur Research Site 35
  • Semnur Research Site 59
  • Semnur Research Site 42

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SP-102

Placebo

Arm Description

SP-102

Placebo

Outcomes

Primary Outcome Measures

Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg
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.

Secondary Outcome Measures

Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)
The ODI is the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. The ODI is a questionnaire completed by the subject that assesses10 topics: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question was scored on a scale of 0-5 with 0 indicating the least amount of disability and 5 indicating the most severe disability. The scores for all questions answered were summed, then multiplied by 2 to obtain the index (range 0 to 100). Zero was equated with no disability and 100 was the maximum disability possible.

Full Information

First Posted
December 8, 2017
Last Updated
August 22, 2022
Sponsor
Scilex Pharmaceuticals, Inc.
Collaborators
Worldwide Clinical Trials, Semnur Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03372161
Brief Title
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Official Title
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
January 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scilex Pharmaceuticals, Inc.
Collaborators
Worldwide Clinical Trials, Semnur Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. The medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment. The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain. The study will also investigate the side effects of SP-102.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Radicular Pain
Keywords
lumbosacral radicular pain, sciatica, leg pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SP-102
Arm Type
Experimental
Arm Description
SP-102
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SP-102
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
injection
Primary Outcome Measure Information:
Title
Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg
Description
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.
Time Frame
Baseline, 4 Weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)
Description
The ODI is the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. The ODI is a questionnaire completed by the subject that assesses10 topics: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question was scored on a scale of 0-5 with 0 indicating the least amount of disability and 5 indicating the most severe disability. The scores for all questions answered were summed, then multiplied by 2 to obtain the index (range 0 to 100). Zero was equated with no disability and 100 was the maximum disability possible.
Time Frame
Baseline, 4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitri Lissin, MD
Organizational Affiliation
Scilex Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Semnur Research Site 75
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36605
Country
United States
Facility Name
Semnur Research Site 52
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Semnur Research Site 58
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Semnur Research Site 18
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Semnur Research Site 47
City
Laguna Woods
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
Semnur Research Site 70
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Semnur Research Site 56
City
Fernandina Beach
State/Province
Florida
ZIP/Postal Code
32024
Country
United States
Facility Name
Semnur Research Site 81
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Semnur Research Site 49
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Semnur Research Site 13
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Semnur Research Site 61
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Semnur Research Site 53
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Semnur Research Site 28
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Semnur Research Site 64
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Semnur Research Site 10
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Semnur Research Site 38
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Semnur Research Site 40
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Semnur Research Site 63
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Semnur Research Site 12
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Semnur Research Site 19
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Semnur Reseach Site 62
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Semnur Research Site 51
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Semnur Research Site 65
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68118
Country
United States
Facility Name
Semnur Research Site 60
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Semnur Research Site 30
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
07702
Country
United States
Facility Name
Semnur Research Site 11
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Semnur Research Site 20
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Semnur Research Site 46
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Semnur Research Site 43
City
Cuyahoga Falls
State/Province
Ohio
ZIP/Postal Code
44223
Country
United States
Facility Name
Semnur Research Site 36
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Semnur Research Site 48
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Semnur Research Site 77
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Semnur Research Site 15
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Semnur Research Site 54
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Semnur Research Site 35
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Semnur Research Site 59
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Semnur Research Site 42
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53220
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

We'll reach out to this number within 24 hrs