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Tests treatment safety and results for Lower Back Pain
Official title Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
ClinicalTrials.gov ID: NCT07122453
What this study is testing
What is CNTX-3001?
CNTX-3001 is an investigational medicine, being studied as a potential treatment for lower back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Three or more classes of pharmacologic treatments
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Napa, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Napa, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.