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Sodium Channel Blocker

Suzetrigine for Diabetic Neuropathy

Phase 3
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weekly average of daily NPRS score ≥4 and ≤9 with limited variation in the 7-day Baseline Period
Body weight ≥45 kilograms
Must not have
Participation in a previous study in which the participant received SUZ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial aims to test how well Suzetrigine works in treating pain in people with diabetic nerve damage.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include dizziness, sleepiness, weight gain (for Pregabalin), as well as any unknown risks associated with Suzetrigine since it's being evaluated for the first time in this context.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My average pain score is between 4 and 9 over the past week.
Select...
I weigh at least 45 kilograms.
Select...
I have diabetes with an HbA1c ≤9% and pain in both legs due to nerve damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have previously participated in a study where I received SUZ.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Suzetrigine (SUZ)Experimental Treatment2 Interventions
Participants will be randomized to receive SUZ.
Group II: PregabalinActive Control2 Interventions
Participants will be randomized to receive Pregabalin.
Group III: PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suzetrigine
2024
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
255 Previous Clinical Trials
33,585 Total Patients Enrolled
~733 spots leftby May 2027
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