Intrathecal CNTX-3001 for intractable chronic low back pain
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Single Ascending Doses of Intrathecal CNTX-3001 in Subjects With Intractable Chronic Moderate to Severe Low Back Pain
This trial will test CNTX-3001, a non-opioid medicine given into the spinal fluid, to see if it is safe and helps adults with long-standing, treatment-resistant moderate to severe low back pain.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Centrexion Therapeutics Industry-sponsored |
| Locations | 1 site (Napa, California) |
| Trial ID | NCT07122453 on ClinicalTrials.gov |
What this trial studies
This Phase 1 first-in-human trial gives CNTX-3001 into the intrathecal space by lumbar puncture to measure safety, tolerability, plasma pharmacokinetics, and early signals of efficacy in people with intractable chronic low back pain. The study includes a placebo arm and enrolls participants who have failed multiple prior therapies including physical modalities, several medication classes, and other interventions. Procedures will include lumbar puncture administration, serial blood sampling for pharmacokinetics, safety monitoring, and pain assessments over the follow-up period. The trial is sponsored by Centrexion Therapeutics in collaboration with NINDS and is conducted at a clinical site in Napa, California.
Who should consider this trial
Good fit: Adults with stable, intractable chronic moderate to severe low back pain who have failed physical therapy, multiple classes of medications, and at least one non-surgical or surgical intervention, and who can safely undergo lumbar puncture are the intended participants.
Not a fit: People whose leg pain is worse than their back pain, those with significant leg weakness, current nicotine users, or those unable or unwilling to undergo lumbar puncture or maintain a stable pain medication regimen may not benefit or be eligible.
Why it matters
Potential benefit: If successful, CNTX-3001 could provide a non-opioid treatment option for people with chronic low back pain who have not benefited from existing therapies.
How similar studies have performed: This is the first-in-human trial of CNTX-3001, though other intrathecal non-opioid agents such as ziconotide have shown benefit in refractory chronic pain but with different safety and tolerability profiles.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Have stable intractable, chronic moderate to severe low back pain * Must have failed all 3 of the following categories of therapies: 1. Physical medicine modalities for at least 6 weeks (e.g., physical therapy, occupational therapy, or chiropractic treatment directed at chronic low back pain) 2. Three or more classes of pharmacologic treatments 3. 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 * 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 this trial is running
Napa, California
- Neurovations — Napa, California, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Operations
- Email: clinicalops@centrexion.com
- Phone: (617) 837-6911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.