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Compares treatment options for Lumbosacral Radicular Pain
Official title Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
ClinicalTrials.gov ID: NCT07264270
What this study is testing
What is C-1101?
C-1101 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for lumbosacral radicular pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
- Body mass index \< 35 kg/m2.
You likely can't join if
- 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.
See the full eligibility criteria
- Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
- Body mass index \< 35 kg/m2.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Broadmeadow, New South Wales, Australia
- Wahroonga, New South Wales, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Broadmeadow, New South Wales, Australia; Wahroonga, New South Wales, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.