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โ† Trials
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Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy

RecruitingPhase 1Ages 18 Years - 70 YearsAllConsano Bio
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care * Body mass index \< 40 kg/m2. Exclusion Criteria: * Presence of clinically significant disease or any other painful condition that may interfere with assessments. * Any condition that currently requires blood or platelet transfusions. * Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder. * Increased risk of bleeding or is taking anticoagulants or platelet aggregation inhibitors. * History or presence of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathies. * History of myocardial infarction within the last 6 months or congestive heart failure. * The presence of an active malignancy or tumor. * Have undergone a surgical procedure for back pain. * Recent use of immunosuppressants, oral steroids, or intravenous steroids.
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What it tests

  • C-1101
  • Placebo: Sterile Saline
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Where

6 sites
Consano Bio Research Site
Fernandina Beach, United States
Consano Bio Research Site
Winston-Salem, United States
Consano Bio Research Site
Richmond, United States
Consano Bio Research Site
Broadmeadow, Australia
Consano Bio Research Site
Wahroonga, Australia
Consano Bio Research Site
Melbourne, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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