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
Centrexion Therapeutics
Summary
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. CNTX-3001 is a novel, non-opioid small molecule
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 no…
Interventions
- DrugCNTX-3001
non-opioid analgesic
- DrugPlacebo
Placebo product
Location
- NeurovationsNapa, California