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

Phase 2

Recruiting

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Drug: VX-993; Drug: Pregabalin; Drug: Placebo (matched to pregabalin); Drug: Placebo (matched to VX-993)

• Registration Number: NCT06619860
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Study Start: 2024-10-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-24
• Primary Completion: 2026-04-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VX-993	VX-993	Participants will be randomized to receive multiple doses of different dose levels of VX-993.
VX-993	Placebo (matched to pregabalin)	Participants will be randomized to receive multiple doses of different dose levels of VX-993.
Pregabalin	Placebo (matched to VX-993)	Participants will be randomized to receive Pregabalin.
Pregabalin	Pregabalin	Participants will be randomized to receive Pregabalin.

Primary Outcome Measures

Name	Time	Method
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
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Day 1 up to Week 16

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (40)

Centre Hospitalier Universitaire de Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

Hôpital Cochin - Centre d'Evaluation et de Traitement de la Douleur (CETD); 🇫🇷 Paris, France

Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord; 🇫🇷 St Priest en Jarez, France

FutureMeds Glasgow; 🇬🇧 Glasgow, United Kingdom

Aintree University Hospital; 🇬🇧 Liverpool, United Kingdom

CHU de Nîmes; 🇬🇧 Nimes, United Kingdom

Cullman Clinical Trials; 🇺🇸 Cullman, Alabama, United States

Trovare Clinical Research; 🇺🇸 Bakersfield, California, United States

Eximia Research-CA, LLC; 🇺🇸 La Mesa, California, United States

Paradigm Clincial Research Centers, LLC., Wheat Ridge; 🇺🇸 Wheat Ridge, Colorado, United States

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