Suzetrigine for Diabetic Neuropathy

Recruiting at 76 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Sensory abnormalities, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

Do I need to stop my current medications to join the trial?

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

What makes the drug Suzetrigine unique for treating diabetic neuropathy?

Suzetrigine (VX-548) is unique because it may offer a novel approach to treating diabetic neuropathy, potentially differing in its mechanism of action compared to existing treatments like trazodone or combinations of herbal injections and vitamins, which are often used but may not be fully effective on their own. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with diabetic peripheral neuropathy who weigh at least 45 kg, have a BMI of 18.0-40.0, and experience consistent pain levels. They must have type 1 or type 2 diabetes with an HbA1c ≤9% and bilateral lower extremity pain due to DPN.

Inclusion Criteria

My average pain score is between 4 and 9 over the past week.

Body mass index (BMI) ≥18.0 to <40.0 kilograms per meter square (kg/m^2)

I weigh at least 45 kilograms.

Exclusion Criteria

I have previously participated in a study where I received SUZ.

More than 3 missing daily NPRS scores during the 7-day Baseline Period

Any sensory abnormality (excluding diabetic peripheral neuropathy) as pre-specified in the protocol

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Suzetrigine, placebo, or Pregabalin to evaluate efficacy, safety, and tolerability

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Suzetrigine (Sodium Channel Blocker)

Trial Overview The study tests the effectiveness and safety of Suzetrigine (SUZ) compared to Pregabalin and placebos in managing pain from diabetic peripheral neuropathy. Participants will be randomly assigned to receive either SUZ, its placebo, Pregabalin, or its placebo.

Participant Groups

Group I: Suzetrigine (SUZ) Experimental Treatment 2 Interventions

Participants will be randomized to receive SUZ.

Group II: Pregabalin Active Control 2 Interventions

Participants will be randomized to receive Pregabalin.

Group III: Placebo Placebo Group 2 Interventions

Participants will be randomized to receive placebo matched to SUZ and 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

Findings from Research

In a phase II study involving 141 patients with painful diabetic neuropathy, low doses of trazodone (10 mg three times daily) showed a trend towards better pain relief compared to placebo, with 62.8% of patients achieving a significant reduction in pain.

While no serious adverse events were reported, the most common side effects included nervous system issues and gastrointestinal disorders, indicating that trazodone may be a safe adjunct treatment for neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study. Lipone, P., Ehler, E., Nastaj, M., et al.[2022]

The combination of SMLH injection and mecobalamin significantly improves the total effective rate of treatment for diabetic peripheral neuropathy (DPN) by 31% compared to mecobalamin alone, based on a review of 15 studies with 1349 participants.

This combination therapy also enhances nerve conduction velocities, showing significant improvements in both motor and sensory conduction velocities of the peroneal and median nerves, indicating a beneficial effect on nerve function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salviae miltiorrhizae and ligustrazine hydrochloride injection combined with mecobalamin for treating diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis. Deng, Z., Wang, M., Fan, Y., et al.[2023]

In a phase-III study involving 165 patients with diabetic polyneuropathy, benfotiamine at a dose of 600 mg per day showed significant improvement in Neuropathy Symptom Score (NSS) after 6 weeks compared to placebo, indicating its efficacy in treating this condition.

The treatment was well tolerated across all groups, suggesting a favorable safety profile, and the higher dose of benfotiamine led to more pronounced improvements, particularly in pain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study. Stracke, H., Gaus, W., Achenbach, U., et al.[2013]

In a study of 31 adult diabetic patients with painful distal symmetrical polyneuropathy, low doses of oral trazodone (50 or 100 mg/day) provided symptomatic relief for 61.3% of participants after 2 weeks, with 22.6% achieving complete relief.

Despite 25.8% of patients discontinuing due to minor side effects like dizziness and headache, the overall findings suggest that low-dose trazodone is an effective treatment option for managing painful diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of low-dose trazodone in the treatment of painful diabetic neuropathy. Wilson, RC.[2022]

A study involving 300 patients with diabetic peripheral neuropathy showed that the combination of ligustrazine and citicoline significantly improved clinical efficacy and symptoms compared to either treatment alone after 4 weeks and maintained benefits at a 3-month follow-up.

No severe adverse reactions were reported, indicating that this combination therapy is both effective and safe for treating diabetic peripheral neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical effect of ligustrazine combined with citicoline for treatment of diabetic peripheral neuropathy]. Liu, Y., Li, N., Ran, XW.[2016]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Salviae miltiorrhizae and ligustrazine hydrochloride injection combined with mecobalamin for treating diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

The use of low-dose trazodone in the treatment of painful diabetic neuropathy. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical effect of ligustrazine combined with citicoline for treatment of diabetic peripheral neuropathy]. [2016]