Corticosteroid Lumbar Epidural Analgesia for Radiculopathy



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:3/21/2019
Start Date:December 8, 2017
End Date:July 31, 2019
Contact:Associate Director Clinical Operations
Email:clinicaltrials@semnurpharma.com
Phone:1-650-386-6709

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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.


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.
We found this trial at
42
sites
1901 South Hawthorne Road
Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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Aurora, Colorado 80012
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Aurora, CO
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Birmingham, Alabama 35235
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Birmingham, AL
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Bloomington, Illinois 61704
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Bloomington, IL
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Boise, Idaho 83704
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Boise, ID
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Burlington, Massachusetts 01805
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Burlington, MA
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301 North Whisman Road
Campbell, California 95008
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Campbell, CA
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Charleston, South Carolina 29406
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Charleston, SC
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Chicago, Illinois 60657
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Chicago, IL
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Cleveland, Ohio 44106
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Cleveland, OH
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Cuyahoga Falls, Ohio 44223
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Cuyahoga Falls, OH
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Draper, Utah 84020
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Draper, UT
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Durham, North Carolina 27710
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Durham, NC
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Fernandina Beach, Florida 32024
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Fernandina Beach, FL
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Greenfield, Wisconsin 53220
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Greenfield, WI
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Greenwood Village, Colorado 80111
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Greenwood Village, CO
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301 North Whisman Road
Houston, Texas 77004
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Houston, TX
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La Jolla, California 92037
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La Jolla, CA
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25251 Paseo De Alicia
Laguna Hills, California 92653
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Laguna Hills, CA
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Laguna Woods, California 92637
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Laguna Woods, CA
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Las Vegas, Nevada 89129
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Las Vegas, NV
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Marietta, Georgia 30060
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Marietta, GA
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Nashville, Tennessee 37212
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Nashville, TN
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New York, New York 10022
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New York, NY
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301 North Whisman Road
Newnan, Georgia 30265
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Newnan, GA
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Oklahoma City, Oklahoma 73109
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Oklahoma City, OK
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301 North Whisman Road
Orlando, Florida 32806
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Orlando, FL
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Overland Park, Kansas 66210
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Overland Park, KS
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Phoenix, Arizona 85053
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Phoenix, AZ
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Plano, Texas 75093
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Plano, TX
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Rochester, New York 14618
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Rochester, NY
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Saint Louis, Missouri 63141
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Saint Louis, MO
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Saint Petersburg, Florida 33709
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Saint Petersburg, FL
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Salt Lake City, Utah 84106
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Salt Lake City, UT
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Santa Monica, California 90404
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Santa Monica, CA
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Shrewsbury, New Jersey 07702
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Shrewsbury, NJ
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Stanford, California 94305
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Stanford, CA
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Tampa, Florida 33603
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Tampa, FL
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Tempe, Arizona 85284
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Tempe, AZ
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Tyler, Texas 75701
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Tyler, TX
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400 Columbia Drive
West Palm Beach, Florida 33409
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West Palm Beach, FL
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Winter Park, Florida 32789
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Winter Park, FL
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