NCT07307976

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

The Analgesic Efficacy and Safety of Oral Medications (Crisugabalin) in Patients With Herpes Zoster

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Herpes Zoster
• Pain

Interventions

Type	Name	Description
DRUG	Crisugabalin combined conventional therapy	In the crisugabalin combined conventional therapy group, crisugabalin will be initiated at 20 mg twice daily. In addition, the group will contain conventional treatment for HZ, except crisugabalin, including NSAIDs, opioids, antiviral drugs and so on.
DRUG	Conventional therapy	In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Timeline

• Start date: 2025-12-15
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2025-12-29
• Last updated: 2026-01-14

Locations

1 site across 1 country: China