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

NCT07307170 | Recruiting DMC

• 1 other identifier: KY2025-369-02-1
• 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. Mirogabalin, 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 mirogabalin 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; Mirogabalin; Pain

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 week 4

  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 week 4 after randomization

Secondary Outcomes (9)

• The worst numeric rating scale score

  at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization

• Proportion of Patients Achieving Pain Reduction

  at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization

• Proportion of patients developing postherpetic neuralgia

  At least 90 days after rash onset

• The type of analgesics and average weekly consumption per analgesics

  at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization

• Herpes Zoster Severity of Illness (HZSOI) Index

  from rash onset to day 90

Study Arms (2)

Mirogabalin group

EXPERIMENTAL

Drug: Mirogabalin combined conventional therapy

Control group

ACTIVE COMPARATOR

Drug: Conventional therapy

Interventions

Mirogabalin combined conventional therapy DRUG

In the mirogabalin group, participants will receive mirogabalin in addition to the same standardized conventional treatment used in the control group, including antiviral therapy, non-opioid analgesics, and opioid analgesics when clinically indicated. Mirogabalin (Mirogabalin Besylate, Daiichi Sankyo Co., ltd, Japan) will be initiated 5 mg twice daily. If the patient's NRS score reaches 0 within the first week, mirogabalin will be discontinued. Otherwise, the dose will be increased to 10 mg twice daily during the second week. If the NRS score reaches 0 within the second week, the dose will be reduced to 5 mg twice daily for 1 week and then discontinued. If pain persists, the dose will be further increased to 15 mg twice daily and maintained until an NRS score of 0 is achieved or until the 90 days after rash onset.

Mirogabalin group

Conventional therapy DRUG

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

Control 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 30 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 mirogabalin;
• \. History of systemic immune diseases, organ transplantation, or cancers;
• \. Pregnancy or breastfeeding;
• \. Suffering from acute or chronic pain disorders other than HZ;
• \. Patients with severe psychiatric disorders, or cognitive impairment.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• The Second Hospital of Hebei Medical University: collaborator
• Second Hospital of Shanxi Medical University: collaborator

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.
• Domon Y, Arakawa N, Inoue T, Matsuda F, Takahashi M, Yamamura N, et al. Binding Characteristics and Analgesic Effects of Mirogabalin, a Novel Ligand for the α2δ Subunit of Voltage-Gated Calcium Channels. J Pharmacol Exp Ther. 2018;365(3):573-82.

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 14, 2025
• First Posted: December 29, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)