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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Mirogabalin combined conventional therapy
  • Conventional therapy

Treatment groups

750 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Tiantan Hospital

Lead sponsor

The Second Hospital of Hebei Medical University

Collaborator

Second Hospital of Shanxi Medical University

Collaborator