VX-993 for Diabetic Neuropathy

Recruiting at 72 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, VX-993, to determine its effectiveness in reducing pain for individuals with Diabetic Peripheral Neuropathy (DPN), a condition causing painful nerve damage in the legs due to diabetes. The study compares VX-993 to the existing medication Pregabalin to evaluate which is more effective and safer. Suitable candidates for this trial have type 1 or type 2 diabetes and have experienced painful leg symptoms from DPN for at least a year. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to the development of potentially more effective pain relief options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VX-993 is generally safe for people. In one study, most participants taking VX-993 experienced only mild to moderate side effects, such as headaches or nausea. Importantly, no serious health problems occurred, indicating the treatment did not cause any major issues. This suggests that VX-993 is well-tolerated by most individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about VX-993 for diabetic neuropathy because it offers a new approach compared to existing treatments like Pregabalin. Most current treatments focus on symptom relief, often without addressing the underlying mechanisms. VX-993 is unique as it targets specific pathways involved in nerve damage, potentially providing more comprehensive protection and relief from pain. This innovative mechanism of action sets VX-993 apart and could lead to more effective and longer-lasting results for patients.

What evidence suggests that VX-993 might be an effective treatment for Diabetic Neuropathy?

Research has shown that VX-993, one of the treatments in this trial, is being tested for its potential to relieve pain in people with Diabetic Peripheral Neuropathy (DPN). Early results are mixed, with some studies not showing significant pain relief in the short term. However, ongoing research in this trial examines its effectiveness over longer periods and with varying doses. Scientists find VX-993 promising because it targets specific nerve pathways that might reduce pain signals. More detailed results are needed to determine its reliability as a treatment for DPN pain. Participants in this trial may also receive Pregabalin, which serves as an active comparator. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06619860

Evaluation of Efficacy and Safety of VX-993 for Pain ... The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral ...

2. clinicaltrials.vrtx.com clinicaltrials.vrtx.com/studies/nct06619860?condition%5Beq%5D=Pain

Evaluation of Efficacy and Safety of VX-993 for Pain ... Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy · Eligibility Criteria · Trial Details · Clinical Site ...

3. biopharmadive.com biopharmadive.com/news/vertex-pain-neuropathic-delay-vx-993-negative-trial/756753/

Vertex plan to build on pain drug breakthrough hits hurdles Vertex continues to enroll a Phase 2 study testing VX-993 in diabetic neuropathic pain. And it could still combine the compound with other ...

4. fiercebiotech.com fiercebiotech.com/biotech/vertex-drops-journavx-follower-acute-pain-after-complete-phase-2-failure

Vertex drops asset in acute pain after phase 2 fail All three dose levels of Nav1.8 inhibitor VX-993 failed to improve pain intensity over a 48-hour period compared to placebo.

5. app.trialscreen.org app.trialscreen.org/trials/phase-2-evaluation-efficacy-safety-vx-993-pain-associated-diabetic-peripheral-trial-nct06619860

Evaluation of Efficacy and Safety of VX-993 for Pain ... A Phase 3 study of VX-993 for diabetic neuropathy pain. Evaluating the effectiveness and safety of VX-993 for pain relief in people with diabetic nerve pain.

6. ctv.veeva.com ctv.veeva.com/study/evaluation-of-efficacy-and-safety-of-vx-993-for-pain-associated-with-diabetic-peripheral-neuropathy

Evaluation of Efficacy and Safety of VX-993 for Pain ... The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral ...

7. investors.vrtx.com investors.vrtx.com/news-releases/news-release-details/vertex-announces-results-phase-2-study-vx-993-treatment-acute

Vertex Announces Results from Phase 2 Study of VX-993 ... VX-993 was generally safe and well tolerated. Most adverse events (AEs) were mild to moderate, and there were no serious adverse events (SAEs) ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06619860?utm_source=trialradar

Evaluation of Efficacy and Safety of VX-993 for Pain ... Key Exclusion Criteria: Painful neuropathy other than DPN; History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s); History of a clinical ...