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

Launched by VERTEX PHARMACEUTICALS INCORPORATED · Sep 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VX-993 to see how well it works and how safe it is for people suffering from pain caused by Diabetic Peripheral Neuropathy (DPN). DPN is a type of nerve damage that can happen in people with diabetes, leading to pain in the legs and feet. The trial is currently looking for participants who are between 65 and 74 years old and have been experiencing this type of pain for at least a year. To qualify, individuals must have diabetes (either type 1 or type 2) with specific blood sugar levels.

Participants in this trial can expect to receive either the study medication or a placebo (a non-active pill) over a set period. The main goal is to find out if VX-993 can help reduce their pain and how well they tolerate it. It's important to note that individuals with other types of nerve pain or certain heart conditions may not be eligible for this study. If you or someone you know fits the criteria and struggles with DPN pain, this trial could be a potential opportunity for relief.

Gender

ALL

Eligibility criteria

• 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.