VX-548 for Peripheral Neuropathy

Recruiting at 49 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vertex Pharmaceuticals Incorporated

Must not be taking: Anti-arrhythmia treatments

Disqualifiers: Painful neuropathy, Cardiac dysrhythmias, Atherosclerotic event, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

192 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called VX-548 to see if it can help reduce pain in people with diabetic nerve pain. The medication works by blocking pain signals from traveling through the nerves.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with type 1 or type 2 diabetes.

Your HbA1c level is less than or equal to 9%.

It seems like there might be a typo or incomplete information. Can you provide more details or clarify the criterion you'd like me to summarize?

Exclusion Criteria

You have nerve pain that is not caused by diabetic peripheral neuropathy.

You have a history of heart rhythm problems that needed medication to treat.

You had a heart attack or stroke in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pregabalin or different dose levels of VX-548

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo (matched to VX-548)
• Pregabalin
• VX-548

Participant Groups

Group I: VX-548 Experimental Treatment 3 Interventions

Participants will be randomized to receive different dose levels of VX-548.

Group II: Pregabalin Active Control 2 Interventions

Participants will receive pregabalin.

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