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

NCT ID: NCT07307170

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Herpes Zoster Mirogabalin Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mirogabalin combined with conventional therapy group

Group Type EXPERIMENTAL

Mirogabalin combined conventional therapy

Intervention Type DRUG

In the mirogabalin combined conventional therapy group, mirogabalin will be initiated at 5 mg twice daily for the first 2 weeks and 10 mg twice daily for the second 2 weeks. From the fifth week, the dosage could be increased to 15 mg twice daily, based on individual patient response and tolerability, with a maximum dose of 15 mg twice daily. In addition, the group will contain conventional treatment for HZ, except mirogabalin, including NSAIDs, opioids, antiviral drugs and so on.

Conventional therapy group

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type DRUG

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

Interventions

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Mirogabalin combined conventional therapy

In the mirogabalin combined conventional therapy group, mirogabalin will be initiated at 5 mg twice daily for the first 2 weeks and 10 mg twice daily for the second 2 weeks. From the fifth week, the dosage could be increased to 15 mg twice daily, based on individual patient response and tolerability, with a maximum dose of 15 mg twice daily. In addition, the group will contain conventional treatment for HZ, except mirogabalin, including NSAIDs, opioids, antiviral drugs and so on.

Intervention Type DRUG

Conventional therapy

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

Intervention Type DRUG

Eligibility Criteria

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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 mirogabalin;
* 4\. History of systemic immune diseases, organ transplantation, or cancers;
* 5\. Pregnancy or breastfeeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fang Luo

Director, Department of Pain Management, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Luo

Role: CONTACT

Phone: 13611326978

Email: [email protected]

Facility Contacts

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Fang Luo

Role: primary

Related Links

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https://pubmed.ncbi.nlm.nih.gov/31741185/

Rosamilia LL. Herpes Zoster Presentation, Management, and Prevention: A Modern Case-Based Review. Am J Clin Dermatol. 2020;21(1):97-107.

https://pubmed.ncbi.nlm.nih.gov/37535772/

Liu Y, Xiao S, Li J, Long X, Zhang Y, Li X. A Network Meta-Analysis of Randomized Clinical Trials to Assess the Efficacy and Safety of Antiviral Agents for Immunocompetent Patients with Herpes Zoster-Associated Pain. Pain Physician. 2023;26(4):337-46.

https://pubmed.ncbi.nlm.nih.gov/29563324/

Domon Y, Arakawa N, Inoue T, Matsuda F, Takahashi M, Yamamura N, et al. Binding Characteristics and Analgesic Effects of Mirogabalin, a Novel Ligand for the α2δ Subunit of Voltage-Gated Calcium Channels. J Pharmacol Exp Ther. 2018;365(3):573-82.

Other Identifiers

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KY2025-369-02-1

Identifier Type: -

Identifier Source: org_study_id