Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain
Status:
NOT_YET_RECRUITING
Trial end date:
2032-03-31
Target enrollment:
Participant gender:
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.