CNTX-3001 for Chronic Low Back Pain
Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
Recruiting
Phase 1
Interventional Study
Lower Back Pain
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 16 (estimated)
- Sponsor
- Centrexion Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with severe chronic low back pain that hasn't improved with other treatments. Participants will receive an experimental drug through a procedure in the lower back.
Are You a Good Fit for This Trial?
You may be able to join if
- I have stable chronic moderate to severe low back pain.
- I have tried physical therapy or similar treatments for at least 6 weeks.
- I have taken three or more different types of pain medications.
- I have had non-surgical or surgical treatments for my back pain.
- I can walk and have normal strength in both legs.
- I am willing and able to have a lumbar puncture.
- I have not smoked or used nicotine products in the last 3 months.
- My body mass index (BMI) is between 18 and 35.
You may not be able to join if
- I have had significant changes in my pain over the last 3 months.
- My back pain occurs only with specific activities or positions.
- I have asthma or another serious breathing problem that needs daily medication.
- I have a history or current diagnosis of cancer (except for skin cancer), heart disease, or bleeding disorders.
- I have fibromyalgia or myalgic encephalomyelitis.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 par…
Trial Locations
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Eligibility Criteria
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 …
Contacts