VX-548 for Sciatica
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of a new treatment, VX-548, for individuals with sciatica caused by lumbar disc problems. Sciatica often involves pain radiating from the lower back to the legs, and the study aims to determine if VX-548 can reduce that pain. Participants will receive either the actual treatment or a placebo (a harmless pill with no active medicine) for up to 12 weeks. Eligible participants typically have experienced sciatica pain for more than three months and have consistent daily pain levels. This trial targets individuals who have not undergone back surgery and whose pain is not due to other nerve issues. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.
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.
Is there any evidence suggesting that VX-548 is likely to be safe for humans?
Research has shown that VX-548 was well-tolerated in past studies. In tests where participants took VX-548 for short-term pain, side effects were similar to those experienced by participants who took a placebo (a harmless pill used for comparison). This indicates that many did not experience serious side effects. VX-548 has effectively reduced pain, especially at higher doses, in other conditions. Since this trial is in an early stage, the researchers are primarily assessing the treatment's safety for sciatica. The evidence so far suggests that VX-548 is generally safe for people, but as with any treatment, monitoring for side effects is important.12345
Why do researchers think this study treatment might be promising for sciatica?
Unlike the standard treatments for sciatica, which typically include NSAIDs, corticosteroids, or physical therapy, VX-548 offers a fresh approach by targeting the nerve pain pathway directly. Researchers are excited about VX-548 because it works by specifically blocking certain pain signals without the side effects often associated with traditional pain medications. This makes VX-548 potentially more effective and safer for long-term use in managing the chronic pain associated with sciatica.
What evidence suggests that VX-548 might be an effective treatment for sciatica?
Research has shown that VX-548, also known as suzetrigine, may help relieve pain from conditions like sciatica. In one study, patients taking VX-548 reported feeling less pain than at the start of the treatment. However, another study found that some patients did not experience more pain relief than those taking a placebo. In this trial, participants will receive either VX-548 or a placebo for up to 12 weeks. This mixed evidence suggests that while VX-548 has potential, its effectiveness can vary from person to person.56789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VX-548 or placebo for up to 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive VX-548 up to 12 weeks.
Participants will receive placebo matched to VX-548 up to 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
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
suzetrigine (VX-548) PHASE 2 RESULTS IN PAINFUL ...
Suzetrigine is an investigational medicine for acute and peripheral neuropathic pain, including lumbosacral radiculopathy. Page 4. global.vrtx.
Evaluation of Efficacy and Safety of VX-548 for Painful ...
It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...
3.
investors.vrtx.com
investors.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-phase-2-study-vx-548-treatmentVertex Announces Positive Results From Phase 2 Study of ...
All VX-548 treatment groups showed statistically significant and clinically meaningful reductions from baseline in pain with mean change in NPRS ...
Vertex's non-opioid pain drug no better than placebo in ...
The results in people with painful lumbosacral radiculopathy (LSR) — also known as sciatica — sent the company's shares down more than 10%.
Vertex pain drug meets study goal, faces ... - STAT News
Those patients reported a 1.98-point pain reduction from baseline, which is statistically no different from the results in the patients who ...
Selective Inhibition of Na V 1.8 with VX-548 for Acute Pain
As compared with placebo, VX-548 at the highest dose, but not at lower doses, reduced acute pain over a period of 48 hours after abdominoplasty ...
VX-548 for Sciatica · Info for Participants
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.
Evaluation of Efficacy and Safety of VX-548 for Acute Pain ...
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy. Conditions.
VX-548 in the treatment of acute pain
These showed that VX-548, when given as an oral loading dose of 100 mg followed by 50 mg 12-hly, significantly decreased pain scores compared ...
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