Actively Recruiting
Phase 3 Study of Suzetrigine Tablets for Treating Pain From Diabetic Peripheral Neuropathy Compared to Pregabalin and Placebo
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-06-15
1100
Participants Needed
76
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Suzetrigine SUZ on pain related to diabetic peripheral neuropathy DPN in adults. This Phase 3 study aims to assess the efficacy, safety, and tolerability of SUZ compared to Pregabalin and placebo in participants experiencing this type of nerve pain. The study is sponsored by Vertex Pharmaceuticals Incorporated and uses a randomized, double-blind design to compare treatments. Participants are randomly assigned to one of three groups to receive oral tablets of Suzetrigine, Pregabalin capsules, or matching placebo tablets. The study treatment is given over a 12-week period, during which participants take their assigned medication. The trial uses a parallel study model with quadruple masking to ensure unbiased results. Throughout the study, participants will report their daily pain levels using the Numeric Pain Rating Scale NPRS. Researchers will measure changes in weekly average pain intensity from baseline to Week 12, comparing SUZ to placebo and Pregabalin. Additional assessments include physical health status using the SF-36 questionnaire. Safety and tolerability will be monitored during the 12-week treatment period. The overall study duration for each participant is up to 12 weeks.
CONDITIONS
Brief Title
Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
Research Team
M
Medical Information
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