Intrathecal CNTX-3001 for intractable chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Neurovations
  Napa, California, United States Recruiting

Study contacts

• Study coordinator: Clinical Operations
• Email: clinicalops@centrexion.com
• Phone: (617) 837-6911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.