CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 194 enrolled
Drug / intervention
Suzetrigine +3 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Diagnosis of type 1 or type 2 diabetes mellitus
  • ✓HbA1c ≤9%
  • ✓Bilateral pain in lower extremities due to diabetic peripheral neuropathy for at least 1 year
Key exclusion· 3
  • ✕Painful neuropathy other than diabetic peripheral neuropathy
  • ✕History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  • ✕History of clinical atherosclerotic event (myocardial infarction or stroke) within the past 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05660538
NCT05660538Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy

Vertex Pharmaceuticals Incorporated·interventional·Posted Dec 21, 2022·Updated Jul 1, 2025

In Brief

A Phase 2 clinical trial evaluating Suzetrigine, Pregabalin, and 2 other interventions for Diabetic Peripheral Neuropathy. Completed, enrolled 194 participants across 50 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedDec 21, 2022
Enrollment StartDec 20, 2022
Primary CompletionOct 12, 2023
Study CompletionOct 25, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.5 years ago

Interventions

Suzetriginedrug

Tablets for oral administration.

Pregabalindrug

Capsules for oral administration.

Placebo (matched to SUZ)drug

Placebo matched to SUZ for oral administration.

Placebo (matched to pregabalin)drug

Placebo matched to pregabalin for oral administration.