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Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

Sponsor
Scilex Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03372161
Collaborator
Worldwide Clinical Trials (Other), Semnur Pharmaceuticals, Inc. (Industry)
401
Enrollment
37
Locations
2
Arms
49
Actual Duration (Months)
10.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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 mediation 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
401 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
Actual Study Start Date :
Dec 8, 2017
Actual Primary Completion Date :
Aug 20, 2021
Actual Study Completion Date :
Jan 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SP-102

SP-102

Drug: SP-102
injection
Placebo Comparator: Placebo

Placebo

Drug: Placebo
injection

Outcome Measures

Primary Outcome Measures

  1. The mean change in leg pain scores using the Numerical Pain Rating Scale (0-10, 0 is no pain, 10 is worst pain imaginable) [Baseline to 4 Weeks]

Secondary Outcome Measures

  1. The change in the Oswestry Disability Index score (0-100, 0 is with no disability, 100 is the maximum disability) [Baseline to 4 Weeks]

  2. The time to repeat injection of SP-102 [Baseline to 4-20 Weeks]

  3. Patient Global Impression of Change [Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24]

  4. Clinical Global Impression of Change [Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 75 Mobile Alabama United States 36605
2 Semnur Research Site 52 Phoenix Arizona United States 85053
3 Semnur Research Site 58 Tempe Arizona United States 85284
4 Semnur Research Site 18 La Jolla California United States 92037
5 Semnur Research Site 47 Laguna Woods California United States 92637
6 Semnur Research Site 70 Los Gatos California United States 95032
7 Semnur Research Site 56 Fernandina Beach Florida United States 32024
8 Semnur Research Site 81 Jacksonville Florida United States 32224
9 Semnur Research Site 49 Saint Petersburg Florida United States 33709
10 Semnur Research Site 13 Tampa Florida United States 33603
11 Semnur Research Site 61 Tampa Florida United States 33603
12 Semnur Research Site 53 Winter Park Florida United States 32789
13 Semnur Research Site 28 Marietta Georgia United States 30060
14 Semnur Research Site 64 Marietta Georgia United States 30060
15 Semnur Research Site 10 Newnan Georgia United States 30265
16 Semnur Research Site 38 Boise Idaho United States 83704
17 Semnur Research Site 40 Bloomington Illinois United States 61704
18 Semnur Research Site 63 Chicago Illinois United States 60607
19 Semnur Research Site 12 Chicago Illinois United States 60612
20 Semnur Research Site 19 Chicago Illinois United States 60657
21 Semnur Reseach Site 62 Overland Park Kansas United States 66210
22 Semnur Research Site 51 Burlington Massachusetts United States 01805
23 Semnur Research Site 65 Omaha Nebraska United States 68118
24 Semnur Research Site 60 Las Vegas Nevada United States 89129
25 Semnur Research Site 30 Shrewsbury New Jersey United States 07702
26 Semnur Research Site 11 Durham North Carolina United States 27710
27 Semnur Research Site 20 Winston-Salem North Carolina United States 27103
28 Semnur Research Site 46 Cleveland Ohio United States 44106
29 Semnur Research Site 43 Cuyahoga Falls Ohio United States 44223
30 Semnur Research Site 36 Oklahoma City Oklahoma United States 73109
31 Semnur Research Site 48 Charleston South Carolina United States 29406
32 Semnur Research Site 77 Greenville South Carolina United States 29615
33 Semnur Research Site 15 Houston Texas United States 77004
34 Semnur Research Site 54 Plano Texas United States 75093
35 Semnur Research Site 35 Tyler Texas United States 75701
36 Semnur Research Site 59 Draper Utah United States 84020
37 Semnur Research Site 42 Greenfield Wisconsin United States 53220

Sponsors and Collaborators

  • Scilex Pharmaceuticals, Inc.
  • Worldwide Clinical Trials
  • Semnur Pharmaceuticals, Inc.

Investigators

  • Study Director: Dmitri Lissin, MD, Scilex Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Scilex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03372161
Other Study ID Numbers:
  • SP-102-02
First Posted:
Dec 13, 2017
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Scilex Pharmaceuticals, Inc.
lumbosacral radicular pain
sciatica
leg pain
Additional relevant MeSH terms:
Radiculopathy

Study Results

No Results Posted as of Jan 31, 2022