About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Crisugabalin combined conventional therapy
Drug
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.
Conventional therapy
Drug
In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Treatment groups

750 Participants

are divided into 2 treatment groups

Group A: Crisugabalin combined with conventional therapy groupExperimental treatment 1 intervention

Group B: Conventional therapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.

Time frame

At maximum tolerated dose

Secondary outcomes

1

The worst numeric rating scale score

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.

Time frame

at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

2

Proportion of Patients Achieving Pain Reduction

The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity

Time frame

at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

3

The 12-item Short-Form Health Survey (SF-12) score

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.

Time frame

at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

4

The Medical Outcomes Study Sleep Scale (MOS)

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).

Time frame

at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts