Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Vertex Pharmaceuticals Incorporated
300 participants
Oct 18, 2024
INTERVENTIONAL
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)
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria3
- 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
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Interventions
Tablets for oral administration.
Capsules for oral administration.
Placebo matched to pregabalin for oral administration.
Placebo matched to VX-993 for oral administration.
Locations(47)
View Full Details on ClinicalTrials.gov
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NCT06619860