Suzetrigine for Diabetic Neuropathy

Recruiting at 91 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Sensory abnormalities, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Suzetrigine for effectiveness in people with diabetic peripheral neuropathy, a condition causing leg pain due to diabetes. Researchers aim to determine if Suzetrigine is safe and effective compared to a placebo or Pregabalin, a medication already used for this condition. Participants must have diabetes and experience regular leg pain from nerve damage caused by diabetes. The study seeks to find a better way to manage the pain associated with this condition. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that Suzetrigine is likely to be safe for humans?

Research has shown that Suzetrigine is generally safe and well-tolerated by most people. In earlier studies, most side effects were mild or moderate. Importantly, no serious side effects were directly linked to Suzetrigine. These early results suggest that the treatment might be safe for those considering joining the clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic neuropathy?

Suzetrigine is unique because it targets diabetic neuropathy in a novel way by potentially offering more effective pain relief than traditional options like pregabalin or gabapentin. Researchers are excited about Suzetrigine because it may work through a different mechanism, focusing on pathways that current drugs do not fully address. This could mean better symptom control and improved quality of life for patients who haven't responded well to existing treatments.

What evidence suggests that Suzetrigine might be an effective treatment for diabetic neuropathy?

Research has shown that Suzetrigine, a medication that blocks pain signals, may help treat painful diabetic peripheral neuropathy (DPN). In this trial, participants will receive either Suzetrigine, Pregabalin, or a placebo. Studies have found that Suzetrigine significantly reduces pain compared to a placebo, with pain relief similar to current treatments like Pregabalin. Suzetrigine blocks specific pathways that send pain signals, helping to reduce pain. Early results from ongoing research continue to support its potential as an effective treatment for people with DPN. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Suzetrigine

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.

How Is the Trial Designed?

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.

Suzetrigine is already approved in United States for the following indications:

Approved in United States as Suzetrigine for:

• Moderate-to-severe acute pain

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05660538

Evaluation of Efficacy and Safety of VX-548 for Painful ... The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN. Official Title. A Phase 2, Randomized, Double-blind, ...

2. investors.vrtx.com investors.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-phase-2-study-vx-548-treatment

Vertex Announces Positive Results From Phase 2 Study of ... Treatment with the NaV1.8 inhibitor VX-548 led to statistically significant and clinically meaningful reduction in the primary endpoint of ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000210760

Suzetrigine, a Selective Pain Signal Inhibitor of NaV1.8 ... Suzetrigine, a Selective Pain Signal Inhibitor of NaV1. 8 Shows Proof-of-concept for Treatment of Painful Diabetic Peripheral Neuropathy (S11. 002) | Neurology.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06628908

Study Details | NCT06628908 | Evaluation of Efficacy and ... The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic ...

5. inpharmd.com inpharmd.com/inquiries/9d8267b3846e8a844e4ca1b61e4b0f9af950d1f6cc47de693077a12a06958bcc

What were the safety and efficacy results from the phase II ... Preliminary, unpublished results from phase 3 trials generally show suzetrigine to produce greater pain reduction than placebo and comparable pain relief to ...