Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain
ConditionLumbosacral Radiculopathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAfasci Inc
About this trial
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.
Eligibility criteria
Qualifiers
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.
MRI imaging is done within 12 months before screening that does not provide evidence of exclusionary pathology (see
Disqualifiers
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
Trial design
Treatments tested in this trial
- AFA-281
Treatment groups
408 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov