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NOT YET RECRUITING
NCT06649747
PHASE2

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

Sponsor: Afasci Inc

View on ClinicalTrials.gov

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.

Official title: A Double-blind, Placebo-controlled, Multi-center Phase II Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral AFA-281 in Patients With Painful Lumbosacral Radiculopathy

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

408

Start Date

2027-04-01

Completion Date

2032-03-31

Last Updated

2025-06-26

Healthy Volunteers

No

Interventions

DRUG

AFA-281

A small molecule, orally available