Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

Lumbosacral Radicular Pain Clinical Trial

Official title:

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372161
• Other study ID #: SP-102-02
• Status: Completed
• Phase: Phase 3
• Start date: December 8, 2017
• Est. completion date: January 6, 2022

Study information

• Verified date: August 2022
• Source: Scilex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: January 6, 2022
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbosacral Radicular Pain
• Radiculopathy

Intervention

Drug:
• SP-102
injection
• Placebo
injection

Locations

Country	Name	City	State
United States	Semnur Research Site 40	Bloomington	Illinois
United States	Semnur Research Site 38	Boise	Idaho
United States	Semnur Research Site 51	Burlington	Massachusetts
United States	Semnur Research Site 48	Charleston	South Carolina
United States	Semnur Research Site 12	Chicago	Illinois
United States	Semnur Research Site 19	Chicago	Illinois
United States	Semnur Research Site 63	Chicago	Illinois
United States	Semnur Research Site 46	Cleveland	Ohio
United States	Semnur Research Site 43	Cuyahoga Falls	Ohio
United States	Semnur Research Site 59	Draper	Utah
United States	Semnur Research Site 11	Durham	North Carolina
United States	Semnur Research Site 56	Fernandina Beach	Florida
United States	Semnur Research Site 42	Greenfield	Wisconsin
United States	Semnur Research Site 77	Greenville	South Carolina
United States	Semnur Research Site 15	Houston	Texas
United States	Semnur Research Site 81	Jacksonville	Florida
United States	Semnur Research Site 18	La Jolla	California
United States	Semnur Research Site 47	Laguna Woods	California
United States	Semnur Research Site 60	Las Vegas	Nevada
United States	Semnur Research Site 70	Los Gatos	California
United States	Semnur Research Site 28	Marietta	Georgia
United States	Semnur Research Site 64	Marietta	Georgia
United States	Semnur Research Site 75	Mobile	Alabama
United States	Semnur Research Site 10	Newnan	Georgia
United States	Semnur Research Site 36	Oklahoma City	Oklahoma
United States	Semnur Research Site 65	Omaha	Nebraska
United States	Semnur Reseach Site 62	Overland Park	Kansas
United States	Semnur Research Site 52	Phoenix	Arizona
United States	Semnur Research Site 54	Plano	Texas
United States	Semnur Research Site 49	Saint Petersburg	Florida
United States	Semnur Research Site 30	Shrewsbury	New Jersey
United States	Semnur Research Site 13	Tampa	Florida
United States	Semnur Research Site 61	Tampa	Florida
United States	Semnur Research Site 58	Tempe	Arizona
United States	Semnur Research Site 35	Tyler	Texas
United States	Semnur Research Site 20	Winston-Salem	North Carolina
United States	Semnur Research Site 53	Winter Park	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Scilex Pharmaceuticals, Inc.	Semnur Pharmaceuticals, Inc., Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4 Weeks
Secondary	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.	Baseline, 4 Weeks