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

NCT06649747 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AFA-281-202
• Study Type: interventional
• Target: 408
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbosacral Radiculopathy

Keywords

Analgesics; Inflammatory pain; Neurologic Diseases; Neuromuscular Diseases; Neuropathic pain,; Peripheral Nervous System Diseases

Outcome Measures

Primary Outcomes (2)

• 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

  2 weeks baseline and 4 weeks of treatment, and 2 weeks after the end of treatment

• Safety- Number of Participants with Treatment-Related Adverse Events (AEs)

  AEs will be assessed by CTCAE v5.0.

  Baseline (2 weeks) and 4 weeks of the treatment, and 4 weeks of followup

Secondary Outcomes (4)

• Tmax

  Predose and Day 28

• Cmax

  Predose and Day 28

• Half life

  Predose and Day 28

• AUC

  Predose and Day 28

Study Arms (4)

Low dose

ACTIVE COMPARATOR

Name: AFA-281; Dosage Form: 5 and 20mg; Dosage: 60mg daily three times a day (TID) for 28 consecutive days

Drug: AFA-281

Mid Dose

ACTIVE COMPARATOR

Name: AFA-281; Dosage Form: 5 and 20mg; Dosage: 120 mg daily three times a day for 28 consecutive days

Drug: AFA-281

High Dose

ACTIVE COMPARATOR

Name: AFA-281; Dosage Form: 5 and 20mg; Dosage: 240 mg daily three times a day for 28 consecutive days

Drug: AFA-281

Placebo

PLACEBO COMPARATOR

Name: Placebo Dosage form: matching study drug Dosage: 0 mg daily three times a day for 28 consecutive days

Drug: AFA-281

Interventions

AFA-281 DRUG

A small molecule, orally available

High Dose; Low dose; Mid Dose; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)
• Presence of spinal cord stimulator.
• 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 .
• Patients who failed a relatively adequate treatment with a tricyclic antidepressants (TAC), selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs)
• Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to:
• Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening
• New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled hypertension
• Clinically significant electrocardiographic (ECG) abnormality per the investigator assessment

Sponsors & Collaborators

• Afasci Inc: lead

MeSH Terms

Conditions

Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xinmin Xie, MD, PhD

  Afasci Inc

  STUDY DIRECTOR

Central Study Contacts

Dennis Gilman, PhD

CONTACT

7752250561; dpgilman@clindm-llc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 21, 2024
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): March 31, 2032
• Study Completion (Estimated): March 31, 2032
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share