The Analgesic Efficacy and Safety of Oral Medications (Mirogabalin) in Patients With Herpes Zoster

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Ages more than 18 years;

• 2\. Patients with onset of HZ rash less than 90 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.

Locations
Other Locations
China
Beijing Tiantan Hospital, Beijing, Beijing 100070
RECRUITING
Beijing
Contact Information
Primary
Fang Luo
13611326978@163.com
13611326978
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 750
Treatments
Experimental: Mirogabalin group
Active_comparator: Control group
Related Therapeutic Areas
Sponsors
Collaborators: The Second Hospital of Hebei Medical University, Second Hospital of Shanxi Medical University
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov