NCT07122453 · Centrexion Therapeutics
Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
What this study is about
This clinical study is being conducted to evaluate the safety, tolerability, plasma how the drug moves through the body and effectiveness of an experimental drug called CNTX-3001. This Phase 1 study is the first time that CNTX-3001 will be given to people (first-in-human study).
View original scientific description
This clinical study is being conducted to evaluate the safety, tolerability, plasma pharmacokinetics and efficacy of an investigational drug called CNTX-3001. This Phase 1 study is the first time that CNTX-3001 will be given to people (first-in-human study). The study is being done to evaluate whether CNTX-3001, given into the intrathecal space by lumbar puncture, can be administered safely to participants who have been diagnosed with intractable chronic moderate to severe low back pain and who have not responded well to other treatments in the past.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have stable intractable, chronic moderate to severe low back pain
- Must have failed all 3 of the following categories of therapies:
- Physical medicine modalities for at least 6 weeks (e.g., physical therapy, occupational therapy, or chiropractic treatment directed at chronic low back pain)
- Three or more classes of pharmacologic treatments
- One or more non-surgical and/or surgical interventions addressing the primary cause of chronic low back pain
- If the intractable low back pain is accompanied by radicular pain, back pain must be dominant over leg pain and may not radiate below the knee
- Has normal leg strength in both legs (able to stand/walk)
- Willing and able to undergo the lumbar puncture
- On a stable analgesic regimen, or a stable dose of an opioid medication for \>3 months
- Non- or ex-smoker and has not used any nicotine-containing products within 3 months
- Men or women able to abide by reproductive and contraceptive requirements
- Has a body mass index (BMI) between 18 and 35 kg/m2, with weight ≥60 kg
Exclusion criteria
- Substantial increase or decrease in pain over the prior 3 months.
- Low back pain that only occurs with specific activities or body positions.
- Has asthma or other severe respiratory disease requiring daily prescription medication
- History of, or current cancer (except basal cell carcinoma), cardiac disease, immunological disorders, meningitis, or bleeding disorders
- Confirmed diagnosis of fibromyalgia or myalgic encephalomyelitis Exclusion
- Substantial increase or decrease in pain over the prior 3 months
- Low back pain that only occurs with specific activities or body positions
- Has asthma or other severe respiratory disease requiring daily prescription medication
- History of, or current cancer (except basal cell carcinoma), cardiac disease, immunological disorders, meningitis, or bleeding disorders
- Confirmed diagnosis of fibromyalgia or myalgic encephalomyelitis
Where
- Napa, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations