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

Official title

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

Overview

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.

Interventions

• Drug Mirogabalin combined conventional therapy
  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 twic
• Drug Conventional therapy
  In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Primary outcome measures

• 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]

Secondary outcome measures (9)

• The worst numeric rating scale score [Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization]
• Proportion of Patients Achieving Pain Reduction [Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization]
• Proportion of patients developing postherpetic neuralgia [Time frame: At least 90 days after rash onset]
• The type of analgesics and average weekly consumption per analgesics [Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization]
• Herpes Zoster Severity of Illness (HZSOI) Index [Time frame: from rash onset to day 90]
• The 12-item Short-Form Health Survey (SF-12) score [Time frame: at weeks 4, 8, 12, 24, and 52 after randomization.]
• The Medical Outcomes Study Sleep Scale (MOS) [Time frame: at weeks 4, 8, 12, 24, and 52 after randomization.]
• Neuropathic Pain Scale [Time frame: at or after 90 days following rash onset]
• Adverse events [Time frame: Through study completion, an average of 52 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing

Identifiers

NCT: NCT07307170 · KY2025-369-02-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗