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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Herpes Zoster
• Intervention / Treatment: Drug: Crisugabalin combined conventional therapy; Drug: Conventional therapy

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo; Phone Number: 13611326978; Email: 13611326978@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital, Beijing, Beijing 100070
    • Contact: Fang Luo; Phone Number: 13611326978; Email: 13611326978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Ages more than 18 years;
• 2. Patients with onset of HZ rash less than 90 days;
• 3. 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);
• 4. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
• 5. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
• 6. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

Exclusion Criteria:

• 1. History of taking gabapentin or pregabalin;
• 2. 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;
• 3. History of intolerance or hypersensitivity to any active components or excipient of the crisugabalin;
• 4. History of systemic immune diseases, organ transplantation, or cancers;
• 5. Pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional therapy group	Drug: Conventional therapy; In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.
Experimental: Crisugabalin combined with conventional therapy group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Achieving Pain Reduction	The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity	at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication
The 12-item Short-Form Health Survey (SF-12) score	The SF-12 score assesses the health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status.	at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication
The Medical Outcomes Study Sleep Scale (MOS)	The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).	at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication
Adverse events	The incidence and proportion of AEs will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state.	Through study completion, an average of 8 weeks
The worst numeric rating scale score	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 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Estimated): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Neurologic Manifestations; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Herpes Zoster
• Other Study ID Numbers: KY2025-369-02-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No