Crisugabalin for shingles pain

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

This study will test whether adding crisugabalin to usual care reduces pain in adults with shingles who have 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: NCT07307976 on ClinicalTrials.gov

What this trial studies

This randomized, controlled study compares crisugabalin plus conventional therapy to conventional therapy alone in adults with herpes zoster who developed rash within the past 90 days and report moderate to severe pain. Participants must have an average pain score of at least 4 on the Numeric Rating Scale and meet basic liver and kidney function criteria. Pain intensity and safety will be tracked over the treatment period using the NRS, laboratory tests, and adverse event reporting. The trial aims to see if crisugabalin provides faster or greater pain relief with acceptable tolerability compared with standard pain management.

Who should consider this trial

Good fit: Adults over 18 with shingles rash onset under 90 days, average pain ≥4 on the NRS, adequate liver enzymes and eGFR ≥30 mL/min/1.73 m2, and no prior use of gabapentin or pregabalin.

Not a fit: Patients with prior gabapentinoid use, disseminated or ocular shingles, severe renal impairment, or known hypersensitivity to crisugabalin are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, adding crisugabalin could provide stronger, better-tolerated relief of acute shingles pain and may lower the chance of developing long-term postherpetic neuralgia.

How similar studies have performed: Gabapentin and pregabalin have shown mixed results for acute herpes zoster pain, and while crisugabalin is approved for other peripheral neuropathic pain, it has not been well studied specifically for acute shingles pain.

Eligibility criteria

Inclusion Criteria:

* 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.

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 crisugabalin;
* 4\. History of systemic immune diseases, organ transplantation, or cancers;
* 5\. Pregnancy or breastfeeding.

Where this trial is running

Beijing

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

Study contacts

• Study coordinator: Fang Luo

Conditions Herpes Zoster; Pain