Actively Recruiting
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
Led by Centrexion Therapeutics · Updated on 2026-03-23
16
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety, tolerability, plasma pharmacokinetics, and effectiveness of an investigational drug called CNTX-3001 in people with intractable chronic moderate to severe low back pain who have not responded well to other treatments. This Phase 1 first-in-human study aims to determine if CNTX-3001, a novel non-opioid small molecule, can be safely given to these participants. The study is sponsored by Centrexion Therapeutics. Participants will receive a single intrathecal injection of either CNTX-3001 or normal saline (placebo) via lumbar puncture. The study is randomized and triple-masked, comparing the investigational drug to placebo. The treatment is administered once, and participants are monitored closely for safety and drug levels. During the study, participants will undergo assessments for adverse events from baseline to Day 7, as well as plasma sampling up to 4 hours post-dose to measure drug concentrations and pharmacokinetics. Researchers will monitor participants' pain levels, leg strength, and overall safety. The total participation period includes the treatment day and follow-up visits during the first week after dosing.
CONDITIONS
Brief 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
- Must have failed all 3 of the following therapies: physical medicine modalities for at least 6 weeks, three or more classes of pharmacologic treatments, and one or more non-surgical and/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 in both legs (able to stand and walk)
- Willing and able to undergo lumbar puncture
- On a stable analgesic or opioid medication dose for more than 3 months
- Non-smoker or ex-smoker with no nicotine use within 3 months
- Men or women able to follow reproductive and contraceptive requirements
- Body mass index between 18 and 35 kg/m2, with 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 body positions
- Has asthma or severe respiratory disease requiring daily prescription medication
- History or current cancer (except basal cell carcinoma), cardiac disease, immunological disorders, meningitis, or bleeding disorders
- Confirmed diagnosis of fibromyalgia or myalgic encephalomyelitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive a single intrathecal injection of CNTX-3001 or placebo to evaluate safety and pharmacokinetics.
Multiple visits from pre-dose to Day 7 for assessments
Trial Site Locations
Total: 1 location
1
Neurovations
Napa, California, United States, 94558
Actively Recruiting
Research Team
C
Clinical Operations
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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