VX-993 for Diabetic Neuropathy

Recruiting at 36 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vertex Pharmaceuticals Incorporated

Must not be taking: Anti-arrhythmics

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: 8-12 weeks

300 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)

Eligibility Criteria

This trial is for people with type 1 or type 2 diabetes who have been experiencing pain in both lower extremities due to Diabetic Peripheral Neuropathy (DPN) for at least a year. Their HbA1c levels must be ≤9%. It's not suitable for individuals who don't meet these specific criteria.

Inclusion Criteria

I have diabetes with an HbA1c level of 9% or lower.

I have had pain in both legs for over a year due to diabetic nerve damage.

Exclusion Criteria

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

I have nerve pain not caused by diabetes.

I am on medication for irregular heartbeats.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of different dose levels of VX-993 or Pregabalin

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VX-993

Trial Overview The study is testing the effectiveness and safety of a new medication called VX-993, comparing it against Pregabalin (an existing drug for DPN pain), and placebo versions of both drugs. Participants will randomly receive one of these treatments to assess their impact on DPN pain.

Participant Groups

Group I: VX-993 Experimental Treatment 2 Interventions

Participants will be randomized to receive multiple doses of different dose levels of VX-993.

Group II: Pregabalin Active Control 2 Interventions

Participants will be randomized to 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