NCT06619860

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy

A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• 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, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	VX-993	Tablets for oral administration.
DRUG	Pregabalin	Capsules for oral administration.
DRUG	Placebo (matched to pregabalin)	Placebo matched to pregabalin for oral administration.
DRUG	Placebo (matched to VX-993)	Placebo matched to VX-993 for oral administration.

Timeline

• Start date: 2024-10-18
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2024-10-01
• Last updated: 2026-03-16

Locations

47 sites across 6 countries: United States, Canada, France, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated drug study