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

Phase 2RecruitingNCT06619860

Vertex Pharmaceuticals Incorporated300 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Diabetic Peripheral Neuropathic Pain

Interventions

VX-993DRUG

Tablets for oral administration.

PregabalinDRUG

Capsules for oral administration.

Placebo (matched to pregabalin)DRUG

Placebo matched to pregabalin for oral administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (47)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: From Baseline up to Week 12

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Day 1 up to Week 16

Central Contacts

Medical Information

CONTACT

617-341-6777 medicalinfo@vrtx.com

Data from ClinicalTrials.gov

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