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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AFA-281
DrugA small molecule, orally available
Treatment groups
408 Participants
are divided into 4 treatment groupsGroup A: Low doseActive comparator 1 intervention
Group B: Mid DoseActive comparator 1 intervention
Group C: High DoseActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric Pain Rating Scale
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable
Time frame
2 weeks baseline and 4 weeks of treatment, and 2 weeks after the end of treatment2
Safety- Number of Participants with Treatment-Related Adverse Events (AEs)
AEs will be assessed by CTCAE v5.0.
Time frame
Baseline (2 weeks) and 4 weeks of the treatment, and 4 weeks of followupSecondary outcomes
1
Tmax
Blood samples collected and analyzed for Tmax
Time frame
Predose and Day 282
Cmax
Blood samples collected and analyzed for Cmax
Time frame
Predose and Day 283
Half life
Blood samples collected and analyzed for half life
Time frame
Predose and Day 284
AUC
Blood samples collected and analyzed for AUC
Time frame
Predose and Day 28Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: