Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: Placebo (matched to pregabalin); Drug: Pregabalin; Drug: VX-548; Drug: Placebo (matched to VX-548)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05660538

VX21-548-103

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

Enrollment: 192 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of diabetes mellitus type 1 or type 2 with

  • Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
  • Presence of bilateral pain in lower extremities due to DPN 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 2 patient groups

VX-548

Experimental group

Description:

Participants will be randomized to receive different dose levels of VX-548.

Treatment:

Drug: VX-548

Drug: Placebo (matched to pregabalin)

Pregabalin

Active Comparator group

Description:

Participants will receive pregabalin.

Treatment:

Drug: Placebo (matched to VX-548)

Drug: Pregabalin