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NCT Number: NCT07307170

The Analgesic Efficacy and Safety of Mirogabalin 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. 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

13611326978

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Ages more than 18 years;
  • 2. Patients with onset of HZ rash less than 30 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 mirogabalin;
  • 4. History of systemic immune diseases, organ transplantation, or cancers;
  • 5. Pregnancy or breastfeeding;
  • 6. Suffering from acute or chronic pain disorders other than HZ;
  • 7. Patients with severe psychiatric disorders, or cognitive impairment.

Treatment and study plan

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.

Conventional therapy

Drug

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

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

    Time frame: At week 4 after randomization

    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.

Secondary outcomes

  1. The worst numeric rating scale score

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

    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.

  2. Proportion of Patients Achieving Pain Reduction

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

    The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity

  3. Proportion of patients developing postherpetic neuralgia

    Time frame: At least 90 days after rash onset

    postherpetic neuralgia is defined as persistent pain in the affected dermatome for at least 90 days after rash onset, with an average pain intensity of ≥3 on the NRS

  4. The type of analgesics and average weekly consumption per analgesics

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

  5. Herpes Zoster Severity of Illness (HZSOI) Index

    Time frame: from rash onset to day 90

    The HZSOI is a severity-by-duration measure of overall pain burden associated with HZ and is typically calculated as the area under the curve of the worst pain scores over a defined period after rash onset.

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

    Time frame: at weeks 4, 8, 12, 24, and 52 after randomization.

    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.

  7. The Medical Outcomes Study Sleep Scale (MOS)

    Time frame: at weeks 4, 8, 12, 24, and 52 after randomization.

    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).

  8. Neuropathic Pain Scale

    Time frame: at or after 90 days following rash onset

    Neuropathic pain characteristics will be assessed using the Neuropathic Pain Scale in participants with developing PHN. The Neuropathic Pain Scale consists of 10 numeric rating items, each scored from 0 to 10, with higher scores indicating greater neuropathic pain severity. The scale assesses pain intensity, unpleasantness, and 8 specific pain qualities, including sharp, hot, dull, cold, sensitive, itchy, deep, and surface pain.

  9. Adverse events

    Time frame: Through study completion, an average of 52 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Second Hospital of Shanxi Medical University
  • The Second Hospital of Hebei Medical University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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