Recruiting
Phase 2

VX-993

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT06619860

Conditions

Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

VX-993

Pregabalin

Placebo (matched to pregabalin)

Placebo (matched to VX-993)

Study Details

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)

Conditions

Diabetic Peripheral Neuropathic Pain

Study ID

NCT06619860

Start date

Oct 18, 2024

Status verified date

Apr, 2026

Completion date

Apr 22, 2027

Anticipated

Primary completion date

Mar 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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/Exclusion criteria may apply.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VX-993

Participants will be randomized to receive multiple doses of different dose levels of VX-993.

active comparator: Pregabalin

Participants will be randomized to receive Pregabalin.

Interventions

VX-993

Tablets for oral administration.

Pregabalin

Capsules for oral administration.

Placebo (matched to pregabalin)

Placebo matched to pregabalin for oral administration.

Placebo (matched to VX-993)

Placebo matched to VX-993 for oral administration.

Primary outcome measure

  • Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 [ Time Frame: From Baseline up to Week 12 ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

Centricity Research Brampton

Recruiting

Brampton, Canada

OCT Research ULC

Recruiting

Kelowna, Canada

Altasciences - Beaumont Clinic Montreal

Recruiting

Montreal, Canada

Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)

Recruiting

Toronto, Canada

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Jun 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-06-01.