CompletedPhase 2

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

United States194 participantsStarted 2022-12-20

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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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.

What they're measuring

Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)

Timeframe: Baseline, At Week 12

Trial details

NCT IDNCT05660538

SponsorVertex Pharmaceuticals Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-12

Results submitted2025-06-13

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials