ClinicalTrials.gov
ClinicalTrials.gov Menu

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03372161
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Semnur Pharmaceuticals, Inc.

December 8, 2017
December 13, 2017
April 23, 2018
December 8, 2017
July 31, 2019   (Final data collection date for primary outcome measure)
The mean change in leg pain scores using the Numerical Pain Rating Scale (0-10, 0 is no pain, 10 is worst pain imaginable) [ Time Frame: Baseline to 4 Weeks ]
The mean change in leg pain scores [ Time Frame: Baseline to 4 Weeks ]
Complete list of historical versions of study NCT03372161 on ClinicalTrials.gov Archive Site
  • The change in the Oswestry Disability Index score (0-100, 0 is with no disability, 100 is the maximum disability) [ Time Frame: Baseline to 4 Weeks ]
  • The time to repeat injection of SP-102 [ Time Frame: Baseline to 4-20 Weeks ]
  • Patient Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
  • Clinical Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
  • The change in disability index scores [ Time Frame: Baseline to 4 Weeks ]
  • The time to repeat injection of SP-102 [ Time Frame: Baseline to 4-20 Weeks ]
  • Patient Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
  • Clinical Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
Not Provided
Not Provided
 
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lumbosacral Radicular Pain
  • Drug: SP-102
    injection
  • Drug: Placebo
    injection
  • Experimental: SP-102
    SP-102
    Intervention: Drug: SP-102
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Same as current
July 31, 2019
July 31, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact: Associate Director Clinical Operations 1-650-386-6709 clinicaltrials@semnurpharma.com
United States
 
 
NCT03372161
SP-102-02
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Semnur Pharmaceuticals, Inc.
Semnur Pharmaceuticals, Inc.
Worldwide Clinical Trials
Study Director: Dmitri Lissin, MD Semnur Pharmaceuticals, Inc.
Semnur Pharmaceuticals, Inc.
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP