New pill combo aims to ease stubborn shingles nerve pain
NCT ID NCT07275762
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hospital for Skin Diseases, Chinese Academy of Medical Sciences
RECRUITINGNanjing, Jiangsu, China
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