Lumbosacral RadiculopathyPhase 2NCT06649747
Safety and Efficacy Study on AFA-281 for the Treatment of Low Back Pain
A Phase 2 study testing AFA-281 in people with Lumbosacral Radiculopathy, run by Afasci Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- AFA-281
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2027to 31 Mar 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 exclusion criteria). CT is acceptable for subjects with contra-indications for MRI.
- 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)
Who cannot join
- 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)
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- 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
- Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Double-blind, Placebo-controlled, Multi-center Phase II Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral AFA-281 in Patients With Painful Lumbosacral Radiculopathy
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.
Read more
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.
Read the 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.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- AFA-281
- Keywords
- Analgesics, Inflammatory pain, Neurologic Diseases, Neuromuscular Diseases, Neuropathic pain,, Peripheral Nervous System Diseases
- Medical subject headings
- Nervous System Diseases, Neuromuscular Diseases, Neuralgia, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFA-281Drug
A small molecule, orally available
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Active comparator | Name: AFA-281; Dosage Form: 5 and 20mg; Dosage: 60mg daily three times a day (TID) for 28 consecutive days Receives: 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 Receives: 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 Receives: 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 Receives: Drug: AFA-281 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline (2 weeks) and 4 weeks of the treatment, and 4 weeks of followup
Secondary outcomes (4)
Tmax
Blood samples collected and analyzed for Tmax
Measured: Predose and Day 28
Cmax
Blood samples collected and analyzed for Cmax
Measured: Predose and Day 28
Half life
Blood samples collected and analyzed for half life
Measured: Predose and Day 28
AUC
Blood samples collected and analyzed for AUC
Measured: Predose and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Apr 2027 (estimated)
- Primary completion31 Mar 2032 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afasci Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinmin Xie, MD, PhD, Study director, Afasci Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649747
- Sponsor's protocol ID
- AFA-281-202
- Status last verified
- Jun 2025
- First submitted
- 14 Oct 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Multi-center Phase II Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral AFA-281 in Patients With Painful Lumbosacral Radiculopathy
- ClinicalTrials.gov ID
- NCT06649747
- Acronym / sponsor ID
- AFA-281-202
- Conditions
- Lumbosacral Radiculopathy
- Keywords
- Analgesics, Inflammatory pain, Neurologic Diseases, Neuromuscular Diseases, Neuropathic pain,, Peripheral Nervous System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Afasci IncIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Mar 2032 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Active comparator | Drug: AFA-281Name: AFA-281; Dosage Form: 5 and 20mg; Dosage: 60mg daily three times a day (TID) for 28 consecutive days |
| Mid Dose | Active comparator | Drug: AFA-281Name: AFA-281; Dosage Form: 5 and 20mg; Dosage: 120 mg daily three times a day for 28 consecutive days |
| High Dose | Active comparator | Drug: AFA-281Name: AFA-281; Dosage Form: 5 and 20mg; Dosage: 240 mg daily three times a day for 28 consecutive days |
| Placebo | Placebo comparator | Drug: AFA-281Name: Placebo Dosage form: matching study drug Dosage: 0 mg daily three times a day for 28 consecutive days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 exclusion criteria). CT is acceptable for subjects with contra-indications for MRI.
- Willing to discontinue current pain medications from 2 weeks before randomization until the end of the clinical study (treatment).
Key exclusion criteria (14 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFA-281A small molecule, orally available | Drug | High Dose, Low dose, Mid Dose, Placebo |
Primary outcome
Numeric Pain Rating Scale
Time frame: 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)
Time frame: Baseline (2 weeks) and 4 weeks of the treatment, and 4 weeks of followup
AEs will be assessed by CTCAE v5.0.
4 secondary outcomes
Tmax
Time frame: Predose and Day 28
Cmax
Time frame: Predose and Day 28
Half life
Time frame: Predose and Day 28
AUC
Time frame: Predose and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinmin Xie, MD, PhD study director
Afasci Inc
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFA-281 in people with Lumbosacral Radiculopathy, run by Afasci Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Gilman, PhD (7752250561, dpgilman@clindm-llc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 2 weeks baseline and 4 weeks of treatment, and 2 weeks after the end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.