Y-4 to Treat the Postherpetic Neuralgia

NCT07275762 | Recruiting Phase 2

• 1 other identifier: Y-4-LC-04
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the efficacy and safety of Y-4 in patients with postherpetic neuralgia(PHN). The main questions it aims to answer are: The efficacy of Y-4 to treat PHN. If drug RK-4 is safe and tolerate in the patients with LHI? Researchers will analyze data from different groups, includes Y-4 group and pregabalin group , to see efficacy of Y-4 and If drug Y-4 is safe and tolerate in the patients with PHN. Participants will :

• Take Y-4 (1w titration period:75 mg pregabalin +18.75 mg riluzole, 12w fixed dose period: 150 mg pregabalin +37.5 mg riluzole, 1w drug withdraw period: 1w titration period:75 mg pregabalin +18.75 mg riluzole) or pregabalin(75 mg for 1w titration period , 150 mg for 12w fixed dose period ,75 mg for 1w drug withdraw period) twice a day for 14 weeks after run-in period (placebo) lasting for 1 week.
• Visit the hospital according to the follow-up schedule agreed upon with your doctor. contact the research staff as soon as possible to reschedule when unable to attend the scheduled study visit.
• Use investigational products as directed by the doctor and undergo the related treatment.
• Inform their investigators of any changes in their health, including any side effects or symptoms, whether or not they believe these changes are related to the trial medication, as well as any new medications they are using or wish to use, or any changes in the dosage of medications they have already taking.
• Use reliable contraceptive methods , such as abstinence, intrauterine devices, double barrier methods (e.g., condom with spermicide or condom with a diaphragm containing spermicide), contraceptive implants, or oral contraceptives (except if the partner is infertile) during the study period and within one month after the study is completed.
• Must inform investigators immediately if they or their partner become pregnant during the study.
• Be sure to inform other doctors being consultant that you are participating in this clinical study.
• Restrict medication use and treatment during the study.

Conditions

Postherpetic Neuralgia; Y-4; Pregabalin

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of Y-4 in patients with PHN by Change from baseline in Average Daily Pain Score (ADPS) for each group at week 13.

  The average daily pain score is a commonly used clinical method for pain assessment. It converts the intensity of pain into numerical values (generally 0-10 points) based on patient self-reports or standardized scales. After recording multiple pain scores each day, an average is calculated to monitor changes in pain and treatment effects dynamically. The core function of pain scoring is to quantify the subjective experience of pain, helping doctors understand the degree of pain and adjust treatment plans. Commonly used scales include: Numeric Rating Scale (NRS): 0 points (no pain) to 10 points (worst pain imaginable).

  week 13

Secondary Outcomes (14)

• Evaluate the efficacy of Y-4 in patients with PHN by ADPS response rate (i.e., proportion of patients with a ≥ 30% and ≥ 50% decrease in ADPS from baseline) at week 13

  week 13

• Evaluate the efficacy of Y-4 in patients with PHN by Change from baseline in Average Daily Pain Score (ADPS) for each group at week 1-12 and 14.

  week 1-12 and 14

• Evaluate the efficacy of Y-4 in patients with PHN by Change from baseline in Score of Average Daily Sleep Interference Score (ADSIS) in each group at week 1-14;

  week 1-14

• Evaluate the efficacy of Y-4 in patients with PHN by The proportion of patients grading ≤2 and ≤3 in each group using Patient Global Impression of Change scale (PGIC) at week 1, 3, 5, 7, 11, 13, 14.

  week 1, 3, 5, 7, 11, 13, 14

• Evaluate the efficacy of Y-4 in patients with PHN by Change from baseline in Simplified McGill Pain Questionnaire (SF-MPQ) in each group at week 1, 3, 5, 7, 9, 11, 13, 14 (single score and total score);

  week 1, 3, 5, 7, 9, 11, 13, 14

Study Arms (2)

Y-4 group

EXPERIMENTAL

participants in this group will use pregabalin and riluzole

Drug: Y-4 tables

pregabalin group

OTHER

participants in this group will use pregabalin only

Drug: Pregabalin

Interventions

Y-4 tables DRUG

combination of pregabalin and riluzole

Y-4 group

Pregabalin DRUG

only use pregabalin

pregabalin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \. VAS score in SF-MPQ ≥ 40 mm of the last 24 hours during screening.

You may not qualify if:

• \. Known previous allergy to the investigational products, rescue medication ingredients, other chemically similar drugs, or excipients.
• \. 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.
• \. 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:
• 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.;
• Chronic digestive diseases, such as liver fibrosis, chronic active hepatitis, peptic ulcer, etc.;
• 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;
• 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);
• Presence of active infection, which, in the opinion of the investigator, is not suitable for entry into this study;
• Diabetic patients with poor glycemic control (peritoneal venous blood glucose ≥11mmol/L at screening);
• Suffering from immunocompromised diseases, such as systemic lupus erythematosus, acquired immunodeficiency syndrome, immunosuppressant therapy for autoimmune diseases.
• \. 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.
• \. 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.
• \. Use prohibited drugs within the first 5 half-lives, or change the restricted drug dosage within the first 14 days.
• \. 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.
• \. Participants already diagnosed with sleep apnea, or those with severe snoring and daytime sleepiness, as well as intermittent hypoxia.

Sponsors & Collaborators

• Neurodawn Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Qianjin Lu

CONTACT

025-85478105; qianlu5860@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)