Mirogabalin for pain relief in people with herpes zoster

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

This will test whether adding mirogabalin to usual care helps adults with recent shingles get better relief from moderate-to-severe pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07307170 on ClinicalTrials.gov

What this trial studies

This randomized, controlled comparison adds mirogabalin to conventional antiviral and analgesic therapy versus conventional therapy alone for adults with acute herpes zoster pain. Eligible participants are adults within 30 days of rash onset who report moderate-to-severe pain (NRS ≥4) and have adequate liver and kidney function; those with prior gabapentin/pregabalin use or disseminated/ocular HZ are excluded. Pain intensity and safety outcomes will be tracked during the treatment period to see if mirogabalin provides stronger analgesia with acceptable tolerability. The trial is led by Beijing Tiantan Hospital with collaboration from regional university hospitals and requires site visits in Beijing.

Who should consider this trial

Good fit: Adults (age >18) with onset of shingles rash within 30 days who have moderate-to-severe pain (NRS ≥4) and acceptable liver (AST/ALT <2× ULN) and renal (eGFR ≥30 mL/min/1.73 m2) function.

Not a fit: Patients with prior gabapentin or pregabalin use, disseminated or ocular herpes zoster, significant renal impairment (eGFR <30), or marked liver enzyme elevations are excluded and may not benefit from this protocol.

Why it matters

Potential benefit: If successful, adding mirogabalin could give patients stronger pain relief with fewer central side effects, possibly reducing acute suffering and the risk of postherpetic neuralgia.

How similar studies have performed: Gabapentinoids have shown mixed results for acute shingles pain, and while mirogabalin is effective for other neuropathic pain, its use in acute herpes zoster is novel and unproven.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Herpes Zoster; Mirogabalin; Pain