Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CNTX-3001, Placebo.
- Who it may be relevant to
- Registry conditions: Lower Back Pain. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- Drug CNTX-3001
non-opioid analgesic - Drug Placebo
Placebo product
Primary outcome measures
- Incidence of treatment emergent adverse events [Time frame: From baseline to the end of treatment visit (Day 7)]
Secondary outcome measures (3)
- Maximum Observed Plasma Concentration (Cmax) of CNTX-3001 [Time frame: Pre dose to up to 4 hours post dose]
- Time to Maximum Observed Plasma Concentration (Tmax) of CNTX-3001 [Time frame: Pre dose to up to 4 hours post dose]
- Area Under the Concentration-time Curve up to the Last Measurable Concentration of CNTX-3001 [Time frame: Pre dose to up to 4 hours post dose]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Neurovations — Napa
Identifiers
NCT: NCT07122453 · CNTX-3001it-LBP-101 · 1UG3NS123965-01