Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

• Sponsor: Semnur Pharmaceuticals, Inc.
• Collaborator: Worldwide Clinical Trials
• Information provided by (Responsible Party): Semnur Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: December 8, 2017
• First Posted Date: December 13, 2017
• Last Update Posted Date: July 4, 2019
• Actual Study Start Date: December 8, 2017
• Estimated Primary Completion Date: January 1, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 12, 2017): 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 ]
• Original Primary Outcome Measures (submitted: December 8, 2017): The mean change in leg pain scores [ Time Frame: Baseline to 4 Weeks ]
• Change History: Complete list of historical versions of study NCT03372161 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: December 12, 2017)

• 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 ]

Original Secondary Outcome Measures (submitted: December 8, 2017)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
• Official Title: Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)

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 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lumbosacral Radicular Pain

Intervention

• Drug: SP-102
  injection
• Drug: Placebo
  injection

Study Arms

• Experimental: SP-102
  SP-102
  Intervention: Drug: SP-102
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 8, 2017): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2020
• Estimated Primary Completion Date: January 1, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Associate Director Clinical Operations; 1-650-386-6709; clinicaltrials@semnurpharma.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03372161
• Other Study ID Numbers: SP-102-02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Semnur Pharmaceuticals, Inc.
• Study Sponsor: Semnur Pharmaceuticals, Inc.
• Collaborators: Worldwide Clinical Trials

Investigators

• Study Director: Dmitri Lissin, MD; Semnur Pharmaceuticals, Inc.

• PRS Account: Semnur Pharmaceuticals, Inc.
• Verification Date: July 2019