New spinal injection offers hope for stubborn back pain
NCT ID NCT07122453
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called CNTX-3001 for people with long-term, moderate to severe low back pain that hasn't gotten better with other treatments. The drug is given as a single injection into the fluid around the spinal cord. The main goal is to check if it's safe and how the body processes it, with a small group of 16 participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Neurovations
RECRUITINGNapa, California, 94558, United States
Contact Email: •••••@•••••
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