Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07307976

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

Led by Beijing Tiantan Hospital · Updated on 2026-01-14

750

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages more than 18 years
  • Onset of herpes zoster rash less than 90 days
  • Moderate to severe herpes zoster pain with an average Numeric Rating Scale score of at least 4
  • Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal
  • Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher
  • Willingness to sign informed consent and ability to comply with study requirements
Not Eligible

You will not qualify if you...

  • History of taking gabapentin or pregabalin
  • Evidence of cutaneous or visceral dissemination of herpes zoster infection or ocular involvement
  • History of intolerance or hypersensitivity to crisugabalin or its components
  • History of systemic immune diseases, organ transplantation, or cancers
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

Actively Recruiting

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Research Team

F

Fang Luo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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