VX-548 for Peripheral Neuropathy

No longer recruiting at 52 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the medication VX-548 to evaluate its effectiveness and safety in treating painful diabetic peripheral neuropathy (DPN), which is nerve pain in the feet and legs due to diabetes. Participants will receive varying doses of VX-548, a new potential drug, or Pregabalin to compare their effects. Suitable candidates for this trial have had type 1 or type 2 diabetes with painful DPN in their legs 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 a chance to contribute to important advancements in DPN treatment.

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?

A previous study found that suzetrigine was generally well tolerated. About 22.9% of participants taking suzetrigine reported side effects, compared to 32.4% in another study group. This finding suggests that suzetrigine might cause fewer side effects than some other treatments.

Pregabalin, used for over ten years, is also known to be well tolerated. Common side effects include dizziness, drowsiness, and swelling in the hands and feet. Most people find these side effects typical but manageable.

Researchers are studying both treatments for their safety in treating pain from diabetic peripheral neuropathy (DPN). This information may help potential trial participants weigh the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for peripheral neuropathy, like Pregabalin, focus on reducing symptoms by altering nerve signaling. But VX-548 works differently, targeting a new mechanism that aims directly at pain pathways in the nervous system. Researchers are excited because VX-548 offers a novel approach that could potentially provide more effective relief with fewer side effects. This unique mechanism might help patients who don't respond well to existing medications, offering a promising new option in neuropathic pain management.

What evidence suggests that this trial's treatments could be effective for Painful DPN?

Research has shown that Suzetrigine (VX-548), which participants in this trial may receive, can significantly reduce pain in individuals with painful diabetic peripheral neuropathy. One study found that it led to a noticeable drop in pain levels on a simple pain rating scale. Suzetrigine blocks a specific pathway, NaV1.8, that transmits pain signals. Pregabalin, another treatment option in this trial, has also proven effective in reducing pain and improving sleep issues related to diabetic peripheral neuropathy. It helps many patients enhance their overall daily functioning and quality of life. Both treatments have shown promising results in managing pain for this condition. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

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

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

You have diabetes, and your HbA1c level is higher than 9%.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

Group I: Suzetrigine (SUZ): Mid Dose Experimental Treatment 2 Interventions

Participants received SUZ 46 mg tablet qd for 12 weeks.

Group II: Suzetrigine (SUZ): Low Dose Experimental Treatment 2 Interventions

Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.

Group III: Suzetrigine (SUZ): High Dose Experimental Treatment 2 Interventions

Participants received SUZ 69 mg tablet qd for 12 weeks.

Group IV: Pregabalin Active Control 2 Interventions

Participants received Pregabalin 100 mg 3 times per day (tid) for 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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2453685/

Efficacy, Safety, and Tolerability of Pregabalin Treatment ... RESULTS—Pooled analysis showed that pregabalin significantly reduced pain and pain-related sleep interference associated with DPN (150, 300, and 600 mg/day ...

2. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2024.1513597/full

Pregabalin vs. gabapentin in the treatment of neuropathic ... Pregabalin demonstrated significant improvement in pain assessed using the VAS scale and in functionality measured by the SF-12/SF-36 and EQ-5D.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1056872725000546

Comparative analysis of the therapeutic effects ... This study aimed to compare the effects of pregabalin, gabapentin, and duloxetine on diabetic peripheral neuropathy (DPN) to guide tailored treatment.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06383702

A Study to Evaluate Pregabalin in Painful Diabetic ... This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3915349/

Pregabalin in Neuropathic Pain: Evidences and Possible ... Pregabalin has shown efficacy in treating fibromyalgia with rapid and clinically significant improvements in several outcome measures related to core symptoms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4110876/

Pregabalin: latest safety evidence and clinical implications for ... After more than a decade of experience with pregabalin, experience and studies have shown that the adverse effect profile of pregabalin is well tolerated for ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/pregabalin-oral-route/description/drg-20067411

Pregabalin (oral route) - Side effects & dosage Pregabalin works in the central nervous system (CNS) to control seizures and pain. It is an anticonvulsant and neuropathic pain agent. This medicine is ...

8. aafp.org aafp.org/pubs/afp/issues/2006/1215/p2093.html

Pregabalin (Lyrica) for the Management of Pain Associated ... Pregabalin is safe and effective for the management of neuropathic pain associated with diabetic peripheral neuropathy.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01701362

Placebo-controlled Safety and Efficacy Study of Pregabalin ... This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4320770/

A Comprehensive Drug Safety Evaluation of Pregabalin in ... The most common AEs with pregabalin were dizziness, somnolence, peripheral edema, and weight increase. Headache, nausea, and diarrhea were less frequent with ...