The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster
The Analgesic Efficacy and Safety of Oral Medications (Mirogabalin) in Patients With Herpes Zoster
Beijing Tiantan Hospital
750 participants
Dec 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- \. 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.
Exclusion Criteria7
- \. 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07307170