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:

• 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

• 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