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

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

Compensation: Varies

Number of Visits: Unknown

218 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

It seems like the criterion you provided is incomplete. Can you please provide more information or context so I can assist you better?

Treatment Details

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.

Participant Groups

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