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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
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.
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
RECRUITINGthe 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.
Time frame: At week 4 after randomization
The worst numeric rating scale score
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.
Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
Proportion of Patients Achieving Pain Reduction
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity
Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
Proportion of patients developing postherpetic neuralgia
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
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
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.
Time frame: from rash onset to day 90
The 12-item Short-Form Health Survey (SF-12) score
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.
Time frame: at weeks 4, 8, 12, 24, and 52 after randomization.
The Medical Outcomes Study Sleep Scale (MOS)
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).
Time frame: at weeks 4, 8, 12, 24, and 52 after randomization.
Neuropathic Pain Scale
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.
Time frame: at or after 90 days following rash onset
Adverse events
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.
Time frame: Through study completion, an average of 52 weeks
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