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

NCT07307976 | Recruiting DMC

• 1 other identifier: KY2025-369-02-2
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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

Pain; Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days at maximum tolerated dose.

  The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

  At maximum tolerated dose

Secondary Outcomes (5)

• The worst numeric rating scale score

  at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

• Proportion of Patients Achieving Pain Reduction

  at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

• The 12-item Short-Form Health Survey (SF-12) score

  at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

• The Medical Outcomes Study Sleep Scale (MOS)

  at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

• Adverse events

  Through study completion, an average of 8 weeks

Study Arms (2)

Crisugabalin combined with conventional therapy group

EXPERIMENTAL

Drug: Crisugabalin combined conventional therapy

Conventional therapy group

ACTIVE COMPARATOR

Drug: Conventional therapy

Interventions

Crisugabalin combined conventional therapy DRUG

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.

Crisugabalin combined with conventional therapy group

Conventional therapy DRUG

In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Conventional therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Ages more than 18 years;
• \. Patients with onset of HZ rash less than 90 days;
• \. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
• \. 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;
• \. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

You may not qualify if:

• \. History of taking gabapentin or pregabalin;
• \. Patients with evidence of cutaneous or visceral dissemination of HZ infection (cutaneous dissemination is defined as more than 20 discrete lesions outside adjacent dermatomes) or ocular involvement of HZ;
• \. History of intolerance or hypersensitivity to any active components or excipient of the crisugabalin;
• \. History of systemic immune diseases, organ transplantation, or cancers;
• \. Pregnancy or breastfeeding.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

RECRUITING

Related Links

• Rosamilia LL. Herpes Zoster Presentation, Management, and Prevention: A Modern Case-Based Review. Am J Clin Dermatol. 2020;21(1):97-107.
• Liu Y, Xiao S, Li J, Long X, Zhang Y, Li X. A Network Meta-Analysis of Randomized Clinical Trials to Assess the Efficacy and Safety of Antiviral Agents for Immunocompetent Patients with Herpes Zoster-Associated Pain. Pain Physician. 2023;26(4):337-46.

MeSH Terms

Conditions

Herpes Zoster; Pain

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fang Luo

CONTACT

13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Pain Management, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)