NCT07307976 The Analgesic Efficacy and Safety of Crisugabalin in Patients With Herpes Zoster
| NCT ID | NCT07307976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Herpes Zoster |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2025-12-15 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Crisugabalin, 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 crisugabalin 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07307976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Herpes Zoster. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07307976 currently recruiting?
Yes, NCT07307976 is actively recruiting participants. Contact the research team at 13611326978@163.com for enrollment information.
Where is the NCT07307976 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07307976 clinical trial?
NCT07307976 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 750 participants.