Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain

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