The Analgesic Efficacy and Safety of Crisugabalin in Patients With Herpes Zoster

Capital Medical University

Status

Enrolling

Conditions

Herpes Zoster

Pain

Treatments

Drug: Conventional therapy

Drug: Crisugabalin combined conventional therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07307976

KY2025-369-02-2

Details and patient eligibility

About

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.

Enrollment

750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.