Lumbosacral Radiculopathy
Conditions
Keywords
Analgesics, Inflammatory pain, Neurologic Diseases, Neuromuscular Diseases, Neuropathic pain,, Peripheral Nervous System Diseases
Brief 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.
Detailed description
This is a randomized, double-blind, placebo-controlled, multicenter Phase II study of the efficacy, safety, tolerability, and PK of oral AFA-281 in 300 patients with painful lumbosacral radiculopathy (PLSR). Patients will be randomized in to the placebo group or doses of AFA-281, titrated over 2 weeks to reach planned daily doses for Weeks 3 and 4. Trials will be conducted simultaneously at 3 sites to meet enrollment targets. The primary efficacy endpoint is 24-hour average pain score based on the 0-10-point Numeric Pain Rating Scale (NPRS) and key secondary endpoint is Oswestry Disability Index (ODI), rates of adverse events, and PK, among others.
Interventions
DRUGAFA-281
A small molecule, orally available
Sponsors
Afasci Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Men or nonpregnant, non-breastfeeding women 18 to 65 years of age who can read and understand written and spoken local language 3. 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. 4. MRI imaging is done within 12 months before screening that does not provide evidence of exclusionary pathology (see
Exclusion criteria
). CT is acceptable for subjects with contra-indications for MRI. 5. Willing to discontinue current pain medications from 2 weeks before randomization until the end of the clinical study (treatment). 6. Numeric rating scale (NRS) ≥4 and ≤9 at screening based on the Patient's Global Impression of Severity (PGI-S)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale | 2 weeks baseline and 4 weeks of treatment, and 2 weeks after the end of treatment | On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable |
| Safety- Number of Participants with Treatment-Related Adverse Events (AEs) | Baseline (2 weeks) and 4 weeks of the treatment, and 4 weeks of followup | AEs will be assessed by CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | Predose and Day 28 | Blood samples collected and analyzed for Tmax |
| Cmax | Predose and Day 28 | Blood samples collected and analyzed for Cmax |
| Half life | Predose and Day 28 | Blood samples collected and analyzed for half life |
| AUC | Predose and Day 28 | Blood samples collected and analyzed for AUC |
Contacts
Primary ContactDennis Gilman, PhD
Outcome results
None listed