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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06619860

Enrollment

300

Registered

2024-10-01

Start date

2024-10-18

Completion date

2026-05-30

Last updated

2026-03-16

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

Conditions

Diabetic Peripheral Neuropathic Pain

Brief 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)

Interventions

DRUGVX-993

Tablets for oral administration.

DRUGPregabalin

Capsules for oral administration.

DRUGPlacebo (matched to pregabalin)

Placebo matched to pregabalin for oral administration.

DRUGPlacebo (matched to VX-993)

Placebo matched to VX-993 for oral administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Diagnosis of diabetes mellitus type 1 or type 2 with * Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and * Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year Key

Exclusion criteria

* Painful neuropathy other than DPN * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) * History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months Other protocol defined Inclusion/

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	From Baseline up to Week 12

Secondary

Measure	Time frame
Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12	From Baseline up to Week 12
Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12	From Baseline up to Week 12
Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12	From Baseline up to Week 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Day 1 up to Week 16

Countries

Canada, France, Germany, Italy, United Kingdom, United States

Contacts

CONTACTMedical Information

medicalinfo@vrtx.com617-341-6777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026