Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

Tracking Information
First Submitted Date ICMJE	December 8, 2017
First Posted Date ICMJE	December 13, 2017
Last Update Posted Date	April 23, 2018
Actual Study Start Date ICMJE	December 8, 2017
Estimated Primary Completion Date	July 31, 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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 ICMJE; (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 ICMJE; (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 ICMJE; (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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Lumbosacral Radicular Pain
Intervention ICMJE	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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: December 8, 2017)	400
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	July 31, 2019
Estimated Primary Completion Date	July 31, 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Associate Director Clinical Operations 1-650-386-6709 clinicaltrials@semnurpharma.com
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT03372161
Other Study ID Numbers ICMJE	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 ICMJE	Semnur Pharmaceuticals, Inc.
Collaborators ICMJE	Worldwide Clinical Trials
Investigators ICMJE	Study Director: Dmitri Lissin, MD Semnur Pharmaceuticals, Inc.
PRS Account	Semnur Pharmaceuticals, Inc.
Verification Date	March 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP