Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Lower Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CNTX-3001

Single intrathecal injection of CNTX-3001

Group Type EXPERIMENTAL

CNTX-3001

Intervention Type DRUG

non-opioid analgesic

Placebo

Single intrathecal injection of normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo product

Interventions

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CNTX-3001

non-opioid analgesic

Intervention Type DRUG

Placebo

Placebo product

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 back pain)
2. Three or more classes of pharmacologic treatments
3. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No