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

ConditionsHerpes ZosterMirogabalinPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

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. Mirogabalin, 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 mirogabalin 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 30 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 mirogabalin;

4. History of systemic immune diseases, organ transplantation, or cancers;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirogabalin combined conventional therapy

    Drug

    In the mirogabalin group, participants will receive mirogabalin in addition to the same standardized conventional treatment used in the control group, including antiviral therapy, non-opioid analgesics, and opioid analgesics when clinically indicated. Mirogabalin (Mirogabalin Besylate, Daiichi Sankyo Co., ltd, Japan) will be initiated 5 mg twice daily. If the patient's NRS score reaches 0 within the first week, mirogabalin will be discontinued. Otherwise, the dose will be increased to 10 mg twice daily during the second week. If the NRS score reaches 0 within the second week, the dose will be reduced to 5 mg twice daily for 1 week and then discontinued. If pain persists, the dose will be further increased to 15 mg twice daily and maintained until an NRS score of 0 is achieved or until the 90 days after rash onset.

  • 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: Mirogabalin groupExperimental treatment 1 intervention
Group B: Control 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 week 4

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 week 4 after randomization

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 weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
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 weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
3

Proportion of patients developing postherpetic neuralgia

postherpetic neuralgia is defined as persistent pain in the affected dermatome for at least 90 days after rash onset, with an average pain intensity of ≥3 on the NRS

Time frame
At least 90 days after rash onset
4

The type of analgesics and average weekly consumption per analgesics

Time frame
at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

The Second Hospital of Hebei Medical University

Collaborator

Second Hospital of Shanxi Medical University

Collaborator

Source ClinicalTrials.gov
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