Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain

Launched by AFASCI INC · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AFA-281 to see if it can help adults with chronic low back and leg pain caused by a condition known as lumbosacral radiculopathy. The trial aims to find out if AFA-281 can reduce pain and what side effects it might have. Participants will take AFA-281 or a placebo (a substance that looks the same but doesn't contain the drug) three times a day for four weeks. They will also visit the clinic every two weeks for check-ups, keep track of their pain levels, and note how their mood and sleep are affected.

To be eligible for this trial, participants need to be between 18 and 65 years old, have been experiencing their pain for at least three months, and must be willing to stop other pain medications for two weeks before starting the study. It's important to note that some people may not qualify due to other health issues or previous treatments. The trial is not yet recruiting participants, so there's still time to learn more and decide if it's right for you or a loved one.

Gender

ALL

Eligibility criteria

• 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)
• Exclusion Criteria:
• • 1. 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)
• • 2. 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
• • 3. History of surgical intervention for LSR at the radicular level of the current pain episode.
• • 4. Current indication for neurosurgery (e.g. progressive motor loss due to compression) or planned surgical intervention for LSR within the duration of the study
• • 5. Has planned surgical intervention for PLSR within the duration of the study. (Subjects with persistent radicular pain after prior surgery are eligible.)
• • 6. Spinal stenosis with neurogenic claudication (pain present during walking and signs of significant lumbar stenosis on existing MRI or CT scan)
• • 7. Presence of spinal cord stimulator.
• • 8. Hypersensitivity/allergic reaction to other T-type calcium agents, such as (but not limited to) ethosuximide, zonisamide, and the mixed sodium and T-type calcium channel blocker lamotrigine and .
• • 9. Patients who failed a relatively adequate treatment with a tricyclic antidepressants (TAC), selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs)
• 10. Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to:
• • 1. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening
• • 2. New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled hypertension
• • 3. Clinically significant electrocardiographic (ECG) abnormality per the investigator assessment
• • 4. Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders