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 |
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.
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
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