Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

NCT03372161 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SP-102-02
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 37

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.

Conditions

Lumbosacral Radicular Pain

Keywords

lumbosacral radicular pain; sciatica; leg pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)

  Baseline, 4 Weeks

Study Arms (2)

SP-102

EXPERIMENTAL

SP-102

Drug: SP-102

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SP-102 DRUG

injection

SP-102

Placebo DRUG

injection

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead
• Worldwide Clinical Trials: collaborator
• Semnur Pharmaceuticals, Inc.: collaborator

Study Sites (37)

Semnur Research Site 75

Mobile, Alabama, 36605, United States

Location

Semnur Research Site 52

Phoenix, Arizona, 85053, United States

Location

Semnur Research Site 58

Tempe, Arizona, 85284, United States

Location

Semnur Research Site 18

La Jolla, California, 92037, United States

Location

Semnur Research Site 47

Laguna Woods, California, 92637, United States

Location

Semnur Research Site 70

Los Gatos, California, 95032, United States

Location

Semnur Research Site 56

Fernandina Beach, Florida, 32024, United States

Location

Semnur Research Site 81

Jacksonville, Florida, 32224, United States

Location

Semnur Research Site 49

St. Petersburg, Florida, 33709, United States

Location

Semnur Research Site 13

Tampa, Florida, 33603, United States

Location

Semnur Research Site 61

Tampa, Florida, 33603, United States

Location

Semnur Research Site 53

Winter Park, Florida, 32789, United States

Location

Semnur Research Site 28

Marietta, Georgia, 30060, United States

Location

Semnur Research Site 64

Marietta, Georgia, 30060, United States

Location

Semnur Research Site 10

Newnan, Georgia, 30265, United States

Location

Semnur Research Site 38

Boise, Idaho, 83704, United States

Location

Semnur Research Site 40

Bloomington, Illinois, 61704, United States

Location

Semnur Research Site 63

Chicago, Illinois, 60607, United States

Location

Semnur Research Site 12

Chicago, Illinois, 60612, United States

Location

Semnur Research Site 19

Chicago, Illinois, 60657, United States

Location

Semnur Reseach Site 62

Overland Park, Kansas, 66210, United States

Location

Semnur Research Site 51

Burlington, Massachusetts, 01805, United States

Location

Semnur Research Site 65

Omaha, Nebraska, 68118, United States

Location

Semnur Research Site 60

Las Vegas, Nevada, 89129, United States

Location

Semnur Research Site 30

Shrewsbury, New Jersey, 07702, United States

Location

Semnur Research Site 11

Durham, North Carolina, 27710, United States

Location

Semnur Research Site 20

Winston-Salem, North Carolina, 27103, United States

Location

Semnur Research Site 46

Cleveland, Ohio, 44106, United States

Location

Semnur Research Site 43

Cuyahoga Falls, Ohio, 44223, United States

Location

Semnur Research Site 36

Oklahoma City, Oklahoma, 73109, United States

Location

Semnur Research Site 48

Charleston, South Carolina, 29406, United States

Location

Semnur Research Site 77

Greenville, South Carolina, 29615, United States

Location

Semnur Research Site 15

Houston, Texas, 77004, United States

Location

Semnur Research Site 54

Plano, Texas, 75093, United States

Location

Semnur Research Site 35

Tyler, Texas, 75701, United States

Location

Semnur Research Site 59

Draper, Utah, 84020, United States

Location

Semnur Research Site 42

Greenfield, Wisconsin, 53220, United States

Location

Related Publications (1)

• Miller A, Candido KD, Knezevic NN, Rivera J, Lunseth P, Levinson DJ, Formoso F, Solanki D, Tavel E, Krull A, Radnovich R, Burkhead D, Souza D, Helm S, Katz N, Dworkin RH, Cohen SP, Rathmell JP, Buvanendran A, Levin J, Stannard E, Ambrose C, Jaros M, Vought K, Lissin D. A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain. Pain. 2024 Dec 1;165(12):2762-2773. doi: 10.1097/j.pain.0000000000003287. Epub 2024 Jun 14.

  PMID: 38875121 DERIVED

MeSH Terms

Conditions

Sciatica

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Associate Director Clinical Operations
• Organization: Scilex Pharmaceuticals, Inc.

cambrose@scilexpharma.com

(650) 386-6709

Study Officials

• Dmitri Lissin, MD

  Scilex Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: December 8, 2017
• Primary Completion: August 20, 2021
• Study Completion: January 6, 2022
• Last Updated: September 19, 2022
• Results First Posted: September 19, 2022

Record last verified: 2022-08

Locations

US (37)