What side effects are associated with this type of intervention?

Common treatments for sciatica include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and anticonvulsants like gabapentin and topiramate. NSAIDs can cause gastrointestinal issues, cardiovascular problems, and kidney damage. Corticosteroid injections may lead to short-term pain relief but can cause side effects such as increased blood sugar levels, weight gain, and osteoporosis with long-term use. Anticonvulsants like gabapentin and topiramate can cause dizziness, fatigue, and cognitive impairment. Treatments similar to VX-548, such as other voltage-activated sodium channel blockers, have shown antinociceptive effects but can also cause side effects like dizziness, nausea, and potential cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Sciatica, primarily focusing on pain management and inflammation reduction. Commonly approved medications include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and anticonvulsants like gabapentin and pregabalin, which are used to manage neuropathic pain. While VX-548, a NaV1.8 inhibitor, is under investigation for its efficacy in treating painful lumbosacral radiculopathy (a condition related to Sciatica), there are no specific FDA-approved NaV1.8 inhibitors for Sciatica as of now. Current treatments aim to alleviate pain and improve function, often involving a combination of pharmacotherapy, physical therapy, and sometimes surgical interventions.

What other types of research exist?

Promising novel alternatives to VX-548 for Sciatica patients include DA-8159, a PDE5 inhibitor shown to induce penile erection in rabbits with spinal cord injury, which may have potential for neuropathic pain management. Additionally, K-134, a PDE3 inhibitor, has demonstrated efficacy in improving gait disturbance and blood flow in rat models of peripheral artery disease, suggesting potential benefits for neuropathic conditions.

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VX-548 for Sciatica

Phase 2

Waitlist Available

Research Sponsored by Vertex Pharmaceuticals Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight greater than or equal to (>=)45 kilogram (kg)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new medication called VX-548 to see if it can help people with PLSR, a condition that might not respond well to typical treatments. The study aims to find out if VX-548 can reduce symptoms or improve health safely.

Who is the study for?

This trial is for individuals who have been experiencing sciatica or radiculopathy pain for more than 3 months. Participants must have a consistent moderate level of pain and meet specific body weight (over 45 kg) and BMI (40 kg/m^2 or less) requirements.

What is being tested?

The study aims to test the effectiveness and safety of a medication called VX-548 in treating painful lumbosacral radiculopathy. Some participants will receive VX-548, while others will be given a placebo to compare results.

What are the potential side effects?

While the side effects of VX-548 are not detailed here, common side effects from similar medications may include nausea, dizziness, headache, or allergic reactions. The trial seeks to identify any potential adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My weight is at least 45 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VX-548Experimental Treatment1 Intervention

Participants will receive VX-548 up to 12 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matched to VX-548 up to 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX-548

2022

Completed Phase 3

~3580

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Sciatica include physical therapy, systemic glucocorticoids, and non-steroidal anti-inflammatory drugs (NSAIDs). Physical therapy helps by improving mobility and strengthening muscles, which can alleviate pressure on the sciatic nerve. Systemic glucocorticoids reduce inflammation and pain by suppressing the immune response. NSAIDs work by inhibiting enzymes (COX-1 and COX-2) involved in the inflammatory process, thereby reducing pain and swelling. NaV1.8 inhibitors, such as VX-548, target the NaV1.8 sodium channel, which is involved in pain signal transmission in sensory neurons. By blocking this channel, these inhibitors can reduce the sensation of pain. Understanding these mechanisms is crucial for Sciatica patients as it helps in selecting the most appropriate treatment based on the underlying cause of their pain and their specific medical condition.

Ononis spinosa alleviated capsaicin-induced mechanical allodynia in a rat model through transient receptor potential vanilloid 1 modulation.Dexmedetomidine Attenuates Neuropathic Pain by Inhibiting P2X7R Expression and ERK Phosphorylation in Rats.

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Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor

251 Previous Clinical Trials

32,646 Total Patients Enrolled

~87 spots leftby Apr 2025

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