Clinical trial NCT03372161: Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Official title: Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lumbosacral Radicular Pain
Keywords: lumbosacral radicular pain
sciatica
leg pain
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
name: Semnur Pharmaceuticals, Inc.
First posted: 2017-12-13
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg
timeFrame: Baseline, 4 Weeks
Secondary outcomes:
measure: Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)
timeFrame: Baseline, 4 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Semnur Research Site 75
state: Alabama
city: Phoenix
country: United States
facility: Semnur Research Site 52
state: Arizona
city: Tempe
country: United States
facility: Semnur Research Site 58
state: Arizona
city: La Jolla
country: United States
facility: Semnur Research Site 18
state: California
city: Laguna Woods
country: United States
facility: Semnur Research Site 47
state: California
city: Los Gatos
country: United States
facility: Semnur Research Site 70
state: California
city: Fernandina Beach
country: United States
facility: Semnur Research Site 56
state: Florida
city: Jacksonville
country: United States
facility: Semnur Research Site 81
state: Florida
city: Saint Petersburg
country: United States
facility: Semnur Research Site 49
state: Florida
city: Tampa
country: United States
facility: Semnur Research Site 13
state: Florida
city: Tampa
country: United States
facility: Semnur Research Site 61
state: Florida
city: Winter Park
country: United States
facility: Semnur Research Site 53
state: Florida
city: Marietta
country: United States
facility: Semnur Research Site 28
state: Georgia
city: Marietta
country: United States
facility: Semnur Research Site 64
state: Georgia
city: Newnan
country: United States
facility: Semnur Research Site 10
state: Georgia
city: Boise
country: United States
facility: Semnur Research Site 38
state: Idaho
city: Bloomington
country: United States
facility: Semnur Research Site 40
state: Illinois
city: Chicago
country: United States
facility: Semnur Research Site 63
state: Illinois
city: Chicago
country: United States
facility: Semnur Research Site 12
state: Illinois
city: Chicago
country: United States
facility: Semnur Research Site 19
state: Illinois
city: Overland Park
country: United States
facility: Semnur Reseach Site 62
state: Kansas
city: Burlington
country: United States
facility: Semnur Research Site 51
state: Massachusetts
city: Omaha
country: United States
facility: Semnur Research Site 65
state: Nebraska
city: Las Vegas
country: United States
facility: Semnur Research Site 60
state: Nevada
city: Shrewsbury
country: United States
facility: Semnur Research Site 30
state: New Jersey
city: Durham
country: United States
facility: Semnur Research Site 11
state: North Carolina
city: Winston-Salem
country: United States
facility: Semnur Research Site 20
state: North Carolina
city: Cleveland
country: United States
facility: Semnur Research Site 46
state: Ohio
city: Cuyahoga Falls
country: United States
facility: Semnur Research Site 43
state: Ohio
city: Oklahoma City
country: United States
facility: Semnur Research Site 36
state: Oklahoma
city: Charleston
country: United States
facility: Semnur Research Site 48
state: South Carolina
city: Greenville
country: United States
facility: Semnur Research Site 77
state: South Carolina
city: Houston
country: United States
facility: Semnur Research Site 15
state: Texas
city: Plano
country: United States
facility: Semnur Research Site 54
state: Texas
city: Tyler
country: United States
facility: Semnur Research Site 35
state: Texas
city: Draper
country: United States
facility: Semnur Research Site 59
state: Utah
city: Greenfield
country: United States
facility: Semnur Research Site 42
state: Wisconsin
Study officials:
affiliation: Scilex Pharmaceuticals, Inc.
name: Dmitri Lissin, MD
role: STUDY_DIRECTOR
References: