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

RecruitingNAAges 18 Years - anyAllBeijing Tiantan Hospital
NCT07307170 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 ฮฑ2ฮด-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 p

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Mirogabalin combined conventional therapy
  • Conventional therapy
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Where

1 site
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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