Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CNTX-3001

    Drug

    non-opioid analgesic

  • Placebo

    Drug

    Placebo product

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: CNTX-3001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment emergent adverse events

Number of participants with TEAEs, which includes laboratory test variables

Time frame
From baseline to the end of treatment visit (Day 7)

Secondary outcomes

1

Maximum Observed Plasma Concentration (Cmax) of CNTX-3001

Time frame
Pre dose to up to 4 hours post dose
2

Time to Maximum Observed Plasma Concentration (Tmax) of CNTX-3001

Time frame
Pre dose to up to 4 hours post dose
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centrexion Therapeutics

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
Apply now