Actively Recruiting
The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster
Led by Beijing Tiantan Hospital · Updated on 2026-03-19
750
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
T
The Second Hospital of Hebei Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Onset of herpes zoster rash less than 30 days ago
- Moderate to severe herpes zoster pain with an average Numeric Rating Scale score of at least 4
- Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal
- Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher
- Ability to understand and sign informed consent and comply with study requirements
You will not qualify if you...
- Previous use of gabapentin or pregabalin
- Evidence of widespread herpes zoster infection beyond nearby skin areas or eye involvement
- History of allergy or intolerance to mirogabalin or its components
- History of systemic immune diseases, organ transplantation, or cancers
- Pregnancy or breastfeeding
- Having acute or chronic pain conditions other than herpes zoster
- Severe psychiatric disorders or cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
Actively Recruiting
Research Team
F
Fang Luo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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