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New pill combo aims to ease stubborn shingles nerve pain

NCT ID NCT07275762

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new tablet called Y-4, which combines two drugs (pregabalin and riluzole), can better relieve postherpetic neuralgia—persistent nerve pain after shingles—compared to pregabalin alone. About 160 adults in China will take either Y-4 or pregabalin for 14 weeks. Researchers will track pain scores and side effects to see if the combination is more effective and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Y-4 (a combination of pregabalin and riluzole)
What this could lead to
If it works, Y-4 could offer better pain relief for people with lingering nerve pain after shingles.
What could go wrong
This is an early Phase 2 trial with only 160 participants, so results may not apply to everyone. The added riluzole may cause side effects without improving pain control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- 1. Able to understand and voluntarily sign the informed consent form. 2. Age ≥ 18 years, any gender. 3. Diagnosed with PHN, meaning pain persists for more than one month after the acute shingles rash has healed. 4\. VAS score in SF-MPQ ≥ 40 mm of the last 24 hours during screening. Exclusion Criteria: * 1\. Known previous allergy to the investigational products, rescue medication ingredients, other chemically similar drugs, or excipients. 2\. During screening, individuals who have been clearly diagnosed with peripheral neuropathy or pain unrelated to PHN (including but not limited to those caused by cerebrovascular disease, Guillain-Barré syndrome, cervical or lumbar spine disorders, osteoarticular or tendon lesions, chronic kidney disease or uremia, thyroid disease, intracranial tumors, trauma, etc.) and are judged by the investigator to potentially confound the assessment of PHN. 3\. During screen, suffer from a systemic disease that, in the opinion of the investigator, may affect the patient's participation in the study or affect the evaluation of the efficacy of PHN, including but not limited to: 1. Severe cardiopulmonary diseases, such as unstable angina, myocardial infarction, severe arrhythmia within 6 months prior to screening, NYHA cardiac function classification of grade III\~IV at screening, hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg at screening), recurrent asthma attacks, etc.; 2. Chronic digestive diseases, such as liver fibrosis, chronic active hepatitis, peptic ulcer, etc.; 3. Neuropsychiatric disorders, including epilepsy, recurrent dizziness or headache, cognitive impairment; Cerebrovascular disease (such as cerebral infarction) or recurrent transient ischemic attack within 6 months prior to screening; 4. History of malignant tumors within 5 years prior to screening (excluding cured basal cell carcinoma of the skin, carcinoma in situ and papillary thyroid carcinoma); 5. Presence of active infection, which, in the opinion of the investigator, is not suitable for entry into this study; 6. Diabetic patients with poor glycemic control (peritoneal venous blood glucose ≥11mmol/L at screening); 7. Suffering from immunocompromised diseases, such as systemic lupus erythematosus, acquired immunodeficiency syndrome, immunosuppressant therapy for autoimmune diseases. 4\. During screening, situations may exist that investigators believe could affect pain assessment, such as if the affected skin area has a skin condition that may influence sensation. 5\. Previously received nerve destruction for PHN, or underwent minimally invasive interventions (such as nerve blocks or neurostimulation), physical therapy (such as red light therapy), or traditional Chinese external treatments (such as acupuncture) within one week prior to screening. 6\. Use prohibited drugs within the first 5 half-lives, or change the restricted drug dosage within the first 14 days. 7\. Severe hematological, hepatatological, and renal function abnormalities at the time of screening, which meet any of the following laboratory test results: 1) Hematology: neutrophil count \< 1.5×109/L, or platelet \< 90×109/L, or hemoglobin \<100g/L; 2) Liver function: ALT or AST \> 2.5 times ULN; or TBIL \> 1.5 times ULN; 3) Renal function: CrCL\<60 mL/min/1.73 m2 (calculated based on Cockroft-Gault formula a); 4) Creatine kinase \>2-fold ULN. 8\. Participants already diagnosed with sleep apnea, or those with severe snoring and daytime sleepiness, as well as intermittent hypoxia. 9\. Participants with a history of suicidal behavior, or those assessed to have suicidal tendencies using the Columbia-Suicide Severity Rating Scale (C-SSRS). 10.Hepatitis B surface antigen (HBsAg) positive and HBV-DNA titer \>lower limit of reference value, or hepatitis C virus antibody (HCV-Ab) positive and HCV-DNA titer \>lower limit of reference value, or human immunodeficiency virus antibody (HIV-Ab) positive, or serum Treponema pallidum-specific antibodies (TP-Ab) positiv eand rapid plasma reagin/toluidine red unheated serum test (RPR or TRUST) positive at screening. 11\. Known drug abuse, or history of alcohol abuse within 1 year prior to screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine). 12\. Pregnant or lactating females. 13.Male (or their partner) or female subjects have a fertility plan during the whole study period and within 1 month after the end of the study or are unwilling to take one or more non-drug contraceptive measures (such as condoms, intrauterine devices, etc.) during the study period. 14.Prior participation in any other clinical study of any other drug within 30 days prior to screening. 15.Engaging in high-altitude work, driving motor vehicles, or operating heavy machinery with associated risks during the study period. 16.Other conditions that are considered unsuitable by the investigator to participate in this clinical study.

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Conditions

The condition(s) this trial relates to.

Neuralgia, Postherpetic postherpetic neuralgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital for Skin Diseases, Chinese Academy of Medical Sciences

    RECRUITING

    Nanjing, Jiangsu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.