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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days at week 4 — 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.

Trial sites (1)

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