NCT05660538

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-12-20
• Primary completion: 2023-10-12
• Completion: 2023-10-25
• First posted: 2022-12-21
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

50 sites across 1 country: United States

Regulatory

• FDA-regulated drug study