Herpes ZosterNCT07307170
The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster
A study testing Mirogabalin combined conventional therapy and Conventional therapy in people with Herpes Zoster and Mirogabalin, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster, Mirogabalin, Pain
- What is being tested?
- Mirogabalin combined conventional therapy and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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.
Who cannot join
- 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;
- 6. Suffering from acute or chronic pain disorders other than HZ;
- 7. Patients with severe psychiatric disorders, or cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing
Fang Luo, 13611326978, 13611326978@163.com
About this study
Official title: The Analgesic Efficacy and Safety of Oral Medications (Mirogabalin) in Patients With Herpes Zoster
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.
- Conditions
- Herpes Zoster, Mirogabalin, Pain
- Being tested
- Mirogabalin combined conventional therapy, Conventional therapy
- Medical subject headings
- Herpes Zoster, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirogabalin combined conventional therapyDrug
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.
In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.
| Study group | Role | What they receive |
|---|---|---|
| Mirogabalin group | Experimental | Not described Receives: Drug: Mirogabalin combined conventional therapy |
| Control group | Active comparator | Not described Receives: Drug: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 4 after randomization
Secondary outcomes (9)
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.
Measured: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
Proportion of Patients Achieving Pain Reduction
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity
Measured: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
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
Measured: At least 90 days after rash onset
The type of analgesics and average weekly consumption per analgesics
Measured: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
Herpes Zoster Severity of Illness (HZSOI) Index
The HZSOI is a severity-by-duration measure of overall pain burden associated with HZ and is typically calculated as the area under the curve of the worst pain scores over a defined period after rash onset.
Measured: from rash onset to day 90
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.
Measured: at weeks 4, 8, 12, 24, and 52 after randomization.
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).
Measured: at weeks 4, 8, 12, 24, and 52 after randomization.
Neuropathic Pain Scale
Neuropathic pain characteristics will be assessed using the Neuropathic Pain Scale in participants with developing PHN. The Neuropathic Pain Scale consists of 10 numeric rating items, each scored from 0 to 10, with higher scores indicating greater neuropathic pain severity. The scale assesses pain intensity, unpleasantness, and 8 specific pain qualities, including sharp, hot, dull, cold, sensitive, itchy, deep, and surface pain.
Measured: at or after 90 days following rash onset
Adverse events
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.
Measured: Through study completion, an average of 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Dec 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Second Hospital of Shanxi Medical University
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307170
- Sponsor's protocol ID
- KY2025-369-02-1
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy and Safety of Oral Medications (Mirogabalin) in Patients With Herpes Zoster
- ClinicalTrials.gov ID
- NCT07307170
- Acronym / sponsor ID
- KY2025-369-02-1
- Conditions
- Herpes Zoster, Mirogabalin, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Second Hospital of Shanxi Medical University
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirogabalin group | Experimental | Drug: Mirogabalin combined conventional therapy |
| Control group | Active comparator | Drug: Conventional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- 5. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirogabalin combined conventional therapyIn 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. | Drug | Mirogabalin group |
| Conventional therapyIn the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on. | Drug | Control group |
Primary outcome
the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days at week 4
Time frame: At week 4 after randomization
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.
9 secondary outcomes
The worst numeric rating scale score
Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
Proportion of Patients Achieving Pain Reduction
Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
Proportion of patients developing postherpetic neuralgia
Time frame: At least 90 days after rash onset
The type of analgesics and average weekly consumption per analgesics
Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52 after randomization
Herpes Zoster Severity of Illness (HZSOI) Index
Time frame: from rash onset to day 90
The 12-item Short-Form Health Survey (SF-12) score
Time frame: at weeks 4, 8, 12, 24, and 52 after randomization.
The Medical Outcomes Study Sleep Scale (MOS)
Time frame: at weeks 4, 8, 12, 24, and 52 after randomization.
Neuropathic Pain Scale
Time frame: at or after 90 days following rash onset
Adverse events
Time frame: Through study completion, an average of 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Rosamilia LL. Herpes Zoster Presentation, Management, and Prevention: A Modern Case-Based Review. Am J Clin Dermatol. 2020;21(1):97-107.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirogabalin combined conventional therapy and Conventional therapy in people with Herpes Zoster and Mirogabalin, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo (13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days at week 4 (time frame: At week 4 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.