VX-548 for Sciatica

Recruiting at 55 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Painful neuropathy, Lumbar spine surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

How does the drug VX-548 for sciatica differ from other treatments?

VX-548 is unique because it is being tested specifically for sciatica, whereas other treatments like non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids are commonly used but have limited and controversial efficacy data for this condition. Unlike traditional treatments, VX-548 may offer a novel approach, potentially targeting different mechanisms of pain relief. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My weight is at least 45 kg.

I have been diagnosed with PLSR for more than 3 months.

Your average daily pain score is between 4 and 10 during the 7-day Run-in Period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VX-548 or placebo for up to 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• VX-548

Trial Overview 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.

How Is the Trial Designed?

Group I: VX-548 Experimental Treatment 1 Intervention

Participants will receive VX-548 up to 12 weeks.

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Citations

1. France pubmed.ncbi.nlm.nih.gov

[Acupuncture and sciatica in the acute phase. Double-blind study of 30 cases]. [2006]

2. India pubmed.ncbi.nlm.nih.gov

Efficacy and safety of lornoxicam compared with placebo and diclofenac in acute sciatica/lumbo-sciatica: an analysis from a randomised, double-blind, multicentre, parallel-group study. [2013]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of lidocaine-coated plates (versatis) in the treatment of back pain]. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Short-term Efficiency and Tolerance of Ketoprofen and Methylprednisolone in Acute Sciatica: A Randomized Trial. [2020]

5. France pubmed.ncbi.nlm.nih.gov

[Non-steroidal anti-inflammatory agents. Evaluation criteria in discal sciatic neuralgia]. [2006]