Crisugabalin for shingles pain
Official title: The Analgesic Efficacy and Safety of Oral Medications (Crisugabalin) in Patients With Herpes Zoster
Run by Beijing Tiantan Hospital · NCT07307976 · Data updated 2026-11-12
This study will test whether adding crisugabalin to usual care reduces pain in adults with shingles who have moderate to severe pain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT07307976 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China Recruiting
Study contacts
- Study coordinator: Fang Luo
- Email: 13611326978@163.com
- Phone: 13611326978
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.