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Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

NCT06628908 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2026-04-28

No results posted yet for this study

Summary

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).

Conditions

  • Diabetic Peripheral Neuropathic Pain

Interventions

DRUG

Suzetrigine

Tablets for oral administration.

DRUG

Placebo (matched to SUZ)

Placebo matched to SUZ for oral administration.

DRUG

Pregabalin

Capsules for oral administration.

DRUG

Placebo (matched to Pregabalin)

Placebo matched to Pregabalin for oral administration.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06628908 on ClinicalTrials.gov