Herpes Zoster, Mirogabalin, Pain
Conditions
Brief 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.
Interventions
DRUGMirogabalin 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.
DRUGConventional therapy
In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.
Sponsors
Beijing Tiantan Hospital
The Second Hospital of Hebei Medical University
Second Hospital of Shanxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The worst numeric rating scale score | 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. |
| Proportion of Patients Achieving Pain Reduction | 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 |
| Proportion of patients developing postherpetic neuralgia | 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 |
| The type of analgesics and average weekly consumption per analgesics | at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization | — |
| Herpes Zoster Severity of Illness (HZSOI) Index | 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. |
| The 12-item Short-Form Health Survey (SF-12) score | 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. |
| The Medical Outcomes Study Sleep Scale (MOS) | 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). |
| Neuropathic Pain Scale | 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. |
| Adverse events | 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. |
Countries
China
Contacts
CONTACTFang Luo
Outcome results
None listed