CNTX-3001 for Low Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new non-opioid drug, CNTX-3001, to evaluate its safety and effectiveness for individuals with serious, long-lasting low back pain. The drug is administered through a lumbar puncture, where medicine is injected into the spine. It targets individuals who have not found relief with physical therapy, pain medication, or surgeries. Ideal participants experience steady, severe back pain that has remained unchanged recently and do not have major health issues like asthma or heart disease. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects on people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be on a stable pain medication regimen for more than 3 months to participate.
Is there any evidence suggesting that CNTX-3001 is likely to be safe for humans?
In a previous study, researchers assessed the safety of CNTX-3001 by examining how well participants tolerated the drug when injected into the spine. CNTX-3001 is a new type of pain medication that differs from traditional painkillers. As this is the first human trial of CNTX-3001, limited information exists about its safety. However, similar studies with other drugs typically focus on side effects and how the body processes the medicine during early testing. This early-phase trial primarily aims to check safety and determine the right dose. Although there is not enough data yet to confirm the safety of CNTX-3001, the trial will carefully monitor for any side effects.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about CNTX-3001 because it targets low back pain through a unique delivery method: a single intrathecal injection. Unlike standard treatments such as oral painkillers and physical therapy, CNTX-3001 is administered directly into the spinal fluid, potentially leading to faster and more effective pain relief. This direct approach could minimize systemic side effects commonly associated with traditional oral medications. By specifically targeting the spinal area, CNTX-3001 may offer a new level of precision in pain management, making it a promising option for those seeking relief from chronic low back pain.
What evidence suggests that CNTX-3001 might be an effective treatment for low back pain?
Research suggests that CNTX-3001, which participants in this trial may receive, could be a promising treatment for low back pain. Studies in rats have shown that delivering CNTX-3001 to the spinal cord provides strong pain relief with fewer side effects than other treatments. This drug targets specific parts of the body's pain-control system called NOP receptors. These receptors help manage pain without the addiction risk associated with traditional opioids. Although studies in humans are just starting, early animal research indicates that CNTX-3001 might also effectively reduce pain in people.12346
Are You a Good Fit for This Trial?
This trial is for individuals with chronic moderate to severe low back pain that hasn't improved with other treatments. Participants will receive the investigational drug CNTX-3001 via lumbar puncture into the intrathecal space, which surrounds the spinal cord.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intrathecal injection of CNTX-3001 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CNTX-3001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centrexion Therapeutics
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator