A Phase 2 Study to Evaluate the Safety and Effectiveness of Oral VX-993 Compared to Pregabalin for Pain from Diabetic Peripheral Neuropathy in Adults

What this Trial Is About

Researchers are studying VX-993 to evaluate its effectiveness, safety, and tolerability in adults with pain caused by Diabetic Peripheral Neuropathy DPN, a condition linked to diabetes that affects nerve function in the lower limbs. This Phase 2 trial compares VX-993 with Pregabalin, an existing medication used to manage this type of pain, to better understand how these treatments work for participants with DPN. Participants are randomly assigned to receive either varying doses of oral VX-993 tablets or Pregabalin capsules. The study is double-blind and includes matched placebos for both treatments to maintain unbiased results. The trial lasts up to 16 weeks, with primary evaluations focused at 12 weeks to measure changes in pain intensity using a numeric scale. During the trial, participants will undergo regular assessments of their daily pain levels and monitoring for any adverse effects. Researchers will track the percentage of pain reduction and evaluate safety through reports of side effects. The study spans from initial screening through treatment and follow-up, with ongoing safety assessments to support participant well-being throughout the process.

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