Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain (NCT06649747) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain
408 participantsStarted 2027-04-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form (ICF) indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, potential benefits, side effects, risks, and discomforts
✓. Men or nonpregnant, non-breastfeeding women 18 to 65 years of age who can read and understand written and spoken local language
✓. Clinical diagnosis of CLBP due to LSR in a dermatomal pattern (L4, L5, or S1) that has been present for at least 3 months at the time of screening.
Exclusion criteria
✕. Willing to discontinue current pain medications from 2 weeks before randomization until the end of the clinical study (treatment).
✕. Numeric rating scale (NRS) ≥4 and ≤9 at screening based on the Patient's Global Impression of Severity (PGI-S)
✕. Neuropathic pain due to other causes rather than LSR (e.g. painful diabetic neuropathy, other neuropathy, spinal abscess, infection, hematoma or malignancy; phantom limb pain)
✕. Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
What they're measuring
1
Numeric Pain Rating Scale
Timeframe: 2 weeks baseline and 4 weeks of treatment, and 2 weeks after the end of treatment
2
Safety- Number of Participants with Treatment-Related Adverse Events (AEs)
Timeframe: Baseline (2 weeks) and 4 weeks of the treatment, and 4 weeks of followup
✕. History of surgical intervention for LSR at the radicular level of the current pain episode.
✕. Current indication for neurosurgery (e.g. progressive motor loss due to compression) or planned surgical intervention for LSR within the duration of the study
✕. Has planned surgical intervention for PLSR within the duration of the study. (Subjects with persistent radicular pain after prior surgery are eligible.)
✕. Spinal stenosis with neurogenic claudication (pain present during walking and signs of significant lumbar stenosis on existing MRI or CT scan)