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Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

S

Scilex

Status and phase

Completed
Phase 3

Conditions

Lumbosacral Radicular Pain

Treatments

Drug: SP-102
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03372161
SP-102-02

Details and patient eligibility

About

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.

Enrollment

401 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

401 participants in 2 patient groups, including a placebo group

SP-102
Experimental group
Description:
SP-102
Treatment:
Drug: SP-102
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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