Evaluating the Safety and Effectiveness of Y-4 Tablets Compared to Pregabalin Capsules for Treating Postherpetic Neuralgia in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a drug called Y-4 for patients with postherpetic neuralgia PHN, a condition where nerve pain continues after shingles rash has healed. This study compares Y-4 to an existing medication, pregabalin, to see which works better and is safer for managing PHN symptoms. The trial is a phase II, randomized, double-blind study involving Chinese patients with this condition. Participants will receive either Y-4 tablets, which combine pregabalin and riluzole, or pregabalin capsules alone. Both treatments start with a one-week titration period at lower doses, followed by a 12-week fixed-dose period, and end with a one-week drug withdrawal period. They will take the medications twice daily during the 14-week treatment phase after a one-week placebo run-in period. During the study, participants will visit the hospital as scheduled for follow-up assessments. They will be monitored for changes in pain levels, sleep interference, anxiety, and depression using various scales and questionnaires. Researchers will also track the use of rescue medication and record any side effects or abnormal test results over the 16-week study. Participants must use reliable contraception during and one month after the study and report any health changes or new medications to the investigators.

Y-4 to Treat the Postherpetic Neuralgia