Actively Recruiting
Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
Led by Centrexion Therapeutics · Updated on 2026-03-23
16
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
C
Centrexion Therapeutics
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have stable intractable, chronic moderate to severe low back pain
- Failed physical medicine treatments for at least 6 weeks (e.g., physical therapy, occupational therapy, chiropractic care)
- Failed three or more classes of pharmacologic treatments
- Failed one or more non-surgical or surgical interventions for low back pain
- If radicular pain is present, back pain must be dominant and not radiate below the knee
- Normal leg strength allowing standing and walking
- Willing and able to undergo lumbar puncture
- On a stable analgesic or opioid dose for more than 3 months
- Non-smoker or ex-smoker with no nicotine use in past 3 months
- Men or women able to meet reproductive and contraceptive requirements
- Body mass index between 18 and 35 kg/m2 and weight at least 60 kg
You will not qualify if you...
- Substantial increase or decrease in pain over the prior 3 months
- Low back pain only occurring with specific activities or positions
- Asthma or severe respiratory disease requiring daily prescription medication
- History or current diagnosis of cancer (except basal cell carcinoma), cardiac disease, immunological disorders, meningitis, or bleeding disorders
- Confirmed diagnosis of fibromyalgia or myalgic encephalomyelitis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Neurovations
Napa, California, United States, 94558
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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