Herpes Zoster, Pain
Conditions
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.
Interventions
DRUGCrisugabalin combined conventional therapy
In the crisugabalin combined conventional therapy group, crisugabalin will be initiated at 20 mg twice daily. In addition, the group will contain conventional treatment for HZ, except crisugabalin, including NSAIDs, opioids, antiviral drugs and so on.
DRUGConventional therapy
In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days at maximum tolerated dose. | At maximum tolerated dose | The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The worst numeric rating scale score | at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication | The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain. |
| Proportion of Patients Achieving Pain Reduction | at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication | The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity |
| The 12-item Short-Form Health Survey (SF-12) score | at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication | The SF-12 score assesses the health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status. |
| The Medical Outcomes Study Sleep Scale (MOS) | at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication | The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence). |
| Adverse events | Through study completion, an average of 8 weeks | The incidence and proportion of AEs will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state. |
Countries
China
Contacts
Primary ContactFang Luo
Outcome results
None listed