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 Painful Diabetic Peripheral Neuropathy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514689-38-01

Acronym

VX24-993-103

Enrollment

Registered

2025-03-26

Start date

2025-05-12

Completion date

Unknown

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Associated With Diabetic Peripheral Neuropathy

Brief summary

Change from baseline in the weekly average of daily pain intensity on the numeric pain rating scale (NPRS) at Week 12

Detailed description

Proportions of subjects with ≥30%, ≥50%, and ≥70% reductions from baseline in the weekly average of daily pain intensity on the NPRS at Week 12, Safety and tolerability based on adverse events (AEs), laboratory test results, vital signs, and ECGs

Interventions

DRUGPregabalin placebo

DRUGVX-993 tablet

DRUGVX-993 Placebo

DRUGPREGABALIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in the weekly average of daily pain intensity on the numeric pain rating scale (NPRS) at Week 12	—

Secondary

Measure	Time frame
Proportions of subjects with ≥30%, ≥50%, and ≥70% reductions from baseline in the weekly average of daily pain intensity on the NPRS at Week 12, Safety and tolerability based on adverse events (AEs), laboratory test results, vital signs, and ECGs	—

Countries

France, Germany, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026