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Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

NCT05660538 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-07-01

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DRUG

Suzetrigine

Tablets for oral administration.

DRUG

Pregabalin

Capsules for oral administration.

DRUG

Placebo (matched to SUZ)

Placebo matched to SUZ 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
2022-12-20
Primary Completion
2023-10-12
Completion
2023-10-25
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 NCT05660538 on ClinicalTrials.gov