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Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain

NCT06649747 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2025-06-26

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate if the drug candidate AFA-281 works to treat chronic low back and leg pain caused by painful lumbosacral radiculopathy (PLSR) in adults. This trial will also evaluate the safety of AFA-281. The main questions it aims to answer are:

* Does AFA-281 mitigate pain?
* What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 works to treat chronic low back and leg pain.

Participants will:

* Take drug AFA-281 or a placebo three times every day for 4 weeks
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of their pain scores and about mood and sleep questionnaires, and the number of times they use a rescue pain medicines.

Conditions

  • Lumbosacral Radiculopathy

Interventions

DRUG

AFA-281

A small molecule, orally available

Sponsors & Collaborators

  • Afasci Inc

    lead INDUSTRY

Principal Investigators

  • Xinmin Xie, MD, PhD · Afasci Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-04-01
Primary Completion
2032-03-31
Completion
2032-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649747 on ClinicalTrials.gov