Y-4 for postherpetic neuralgia

A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Y-4 Tablets in Chinese Patients With Postherpetic Neuralgia, Compared With Pregabalin Capsules

This will test whether Y-4 reduces nerve pain in adults with postherpetic neuralgia compared with pregabalin.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Neurodawn Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07275762 on ClinicalTrials.gov

What this trial studies

Adults with postherpetic neuralgia will be assigned to either a Y-4 group (a combination of pregabalin plus riluzole) or a pregabalin group and treated after a one-week placebo run-in. Dosing includes a 1-week titration, a 12-week fixed-dose period, and a 1-week withdrawal, with medications taken twice daily for 14 weeks total after run-in. The trial measures pain intensity (entry requires SF-MPQ VAS ≥40 mm) and monitors safety and tolerability throughout treatment. Outcomes will compare pain relief and adverse events between the Y-4 regimen and standard pregabalin dosing.

Who should consider this trial

Good fit: Adults aged 18 or older with postherpetic neuralgia (pain persisting more than one month after the shingles rash healed) and a screening SF-MPQ VAS score of at least 40 mm who can consent are eligible.

Not a fit: Patients with other causes of neuropathic pain, known allergy to study drugs or excipients, or systemic conditions judged to confound PHN assessment are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, Y-4 could offer better pain relief or improved tolerability compared with pregabalin alone for adults with PHN.

How similar studies have performed: Pregabalin is an established treatment for PHN, but combining pregabalin with riluzole (Y-4) is a novel approach with limited prior clinical evidence.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Hospital for Skin Diseases, Chinese Academy of Medical Sciences — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Qianjin Lu

Conditions Postherpetic Neuralgia; Y-4; Pregabalin