drugset / Trial / NCT07307976

The Analgesic Efficacy and Safety of Crisugabalin in Patients With Herpes Zoster

NCT07307976

Recruiting 750 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Gabapentinoids such as gabapentin and pregabalin are recommended adjuncts, but their efficacy in acute HZ is inconsistent and often accompanied by adverse effects that limit tolerability. Crisugabalin, a newer gabapentinoid approved for peripheral neuropathic pain, has higher affinity and slower dissociation from the α2δ-1 subunit, suggesting stronger analgesia with fewer central side effects. However, its role in managing acute HZ pain remains unknown. We therefore hypothesize that adding crisugabalin to conventional therapy will provide superior pain relief compared with standard treatment alone, and propose a prospective, randomized, controlled, open-label, blinded-endpoint trial to evaluate this.

Timeline

Start
2025-12-15
Primary completion
2027-09-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject HSK16149 Unknown 20 mg Oral

Indications