Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
ConditionLower Back Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentrexion Therapeutics
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 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
Eligibility criteria
Qualifiers
Have stable intractable, chronic moderate to severe low back pain
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- CNTX-3001
- Placebo
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Centrexion Therapeutics
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov