Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

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ClinicalTrials.gov Identifier: NCT03372161

Recruitment Status : Recruiting

First Posted : December 13, 2017

Last Update Posted : October 22, 2018

See Contacts and Locations

Sponsor:

Collaborator:

Worldwide Clinical Trials

Information provided by (Responsible Party):

Semnur Pharmaceuticals, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lumbosacral Radicular Pain	Drug: SP-102 Drug: Placebo	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
Actual Study Start Date :	December 8, 2017
Estimated Primary Completion Date :	July 31, 2019
Estimated Study Completion Date :	July 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: SP-102 SP-102	Drug: SP-102 injection
Placebo Comparator: Placebo Placebo	Drug: Placebo injection

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372161

Contacts


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

Show 43 Study Locations

Sponsors and Collaborators

Semnur Pharmaceuticals, Inc.

Worldwide Clinical Trials

Investigators


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

More Information

Additional Information:

Study website This link exits the ClinicalTrials.gov site


Responsible Party:	Semnur Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT03372161 History of Changes
Other Study ID Numbers:	SP-102-02
First Posted:	December 13, 2017 Key Record Dates
Last Update Posted:	October 22, 2018
Last Verified:	October 2018


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

Keywords provided by Semnur Pharmaceuticals, Inc.:


lumbosacral radicular pain sciatica leg pain

Additional relevant MeSH terms:


Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases

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