Postherpetic NeuralgiaPhase 2NCT07275762
Y-4 to Treat the Postherpetic Neuralgia
A Phase 2 study testing Y-4 tables and Pregabalin in people with Postherpetic Neuralgia and Y-4, run by Neurodawn Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 and safety of Y-4 to treat PHN compared with pregabalin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Y-4, Pregabalin
- What is being tested?
- Y-4 tables and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 30 Nov 2026
- Phase
- Phase 2
- 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. 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.
Who cannot join
- 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:
- 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;
Show all 22Show fewer
- 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.
- 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.
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
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu
Qianjin Lu, 86-025-85478037, qianlu5860@gmail.com
About this study
Official title: 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
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 and safety of Y-4 to treat PHN compared with pregabalin.
Read more
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
- Being tested
- Y-4 tables, Pregabalin
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-4 tablesDrug
combination of pregabalin and riluzole
PregabalinDrug
only use pregabalin
| Study group | Role | What they receive |
|---|---|---|
| Y-4 group | Experimental | Participants will take Y-4 tablets (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) , BID Receives: Drug: Y-4 tables |
| pregabalin group | Other | Participants will take pregabalin capsules (75 mg for 1w titration period , 150 mg for 12w fixed dose period ,75 mg for 1w drug withdraw period), BID. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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.
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).
Measured: 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;
The subject will select the number that best describes his or her sleep interference experience during the past 24 hours on a scale of 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep)
Measured: 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.
The items of PGIC are listed as follows Score PGIC
- Very much improved
- Much improved
- Minimally improved
- No change
- Worse
- Much worse
- Very much worse
Measured: 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);
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.(Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, sickening, Fearful, Punishing-cruel)
Measured: week 1, 3, 5, 7, 9, 11, 13, 14
Evaluate the efficacy of Y-4 in patients with PHN by Change from baseline in Hospital Anxiety and Depression Scale (HADS) at week 1, 3, 5, 7, 9, 11, 13, 14
The Hospital Anxiety and Depression Scale (HADS) is a psychological assessment tool used to screen for anxiety and depression in patients at general hospitals. It was first developed by Zigmond and Snaith in 1983. The scale contains 14 items, divided into two subscales: anxiety (A) and depression (D), each consisting of 7 questions. Each item is scored on a 4-point scale from 0 to 3, with the total score for each subscale ranging from 0 to 21. Scores of 0-7 indicate no symptoms, 8-10 suggest possible symptoms, and 11-21 indicate definite symptoms. HADS was designed to avoid the use of indicators affected by physical illnesses and is suitable for screening psychological issues in patients with chronic diseases.
Measured: week 1, 3, 5, 7, 9, 11, 13, 14
Evaluate the efficacy of Y-4 in patients with PHN by The amount of rescue medication acetaminophen tablets used by each group during the trial
4-6 h per time, The maximum daily dose should not exceed 2.0 g, and continuous use should not exceed 5 days.
Measured: the whole study（16 week）
Evaluate the safety of Y-4 in patients with PHN by The incidence of treatment-emergent adverse events (TEAE) in each group.
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment.
The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of CTCAE 5.0.
The relevance evaluation is divided into 5 grades: 1-certainly related; 2-probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
Measured: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by rates of Significant Adverse Events.
Significant Adverse Events refers to any adverse event, other than a serious adverse event, that leads to the implementation of targeted medical measures (such as drug withdrawal, dose reduction, and symptomatic treatment) and is significant in blood or other laboratory tests.
Measured: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by rates of Serious Adverse Events (SAE) after treatment.
Serious Adverse Events (SAE) refers to adverse medical events that occur after a subject receives the investigational products, including death, life-threatening conditions, permanent or severe disability or functional loss, the subject requiring hospitalization or an extension of hospital stay, as well as congenital anomalies or birth defects.
Measured: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by incidence of subject getting abnormal results of vital signs after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(blood pressure, respiration, pulse, body temperature will be assessed by according equipments.(electronic sphygmomanometer thermometer).
Measured: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by incidence of subject getting abnormal results of physical examinations after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation
Measured: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by incidence of subject getting abnormal results of 12-lead ECG after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Measured: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by incidence of subject getting abnormal results of laboratory tests after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Measured: the whole study (16 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start2 Feb 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275762
- Sponsor's protocol ID
- Y-4-LC-04
- Status last verified
- May 2026
- First submitted
- 28 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07275762
- Acronym / sponsor ID
- Y-4-LC-04
- Conditions
- Postherpetic Neuralgia, Y-4, Pregabalin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 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.
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 and safety of Y-4 to treat PHN compared with pregabalin.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-4 group | Experimental | Drug: Y-4 tablesParticipants will take Y-4 tablets (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) , BID |
| pregabalin group | Other | Drug: PregabalinParticipants will take pregabalin capsules (75 mg for 1w titration period , 150 mg for 12w fixed dose period ,75 mg for 1w drug withdraw period), BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (22 listed)
- 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:
- 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.
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 |
|---|---|---|
| Y-4 tablescombination of pregabalin and riluzole | Drug | Y-4 group |
| Pregabalinonly use pregabalin | Drug | pregabalin group |
Primary outcome
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.
Time frame: 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).
14 secondary outcomes
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
Time frame: 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.
Time frame: 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;
Time frame: 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.
Time frame: 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);
Time frame: week 1, 3, 5, 7, 9, 11, 13, 14
Evaluate the efficacy of Y-4 in patients with PHN by Change from baseline in Hospital Anxiety and Depression Scale (HADS) at week 1, 3, 5, 7, 9, 11, 13, 14
Time frame: week 1, 3, 5, 7, 9, 11, 13, 14
Evaluate the efficacy of Y-4 in patients with PHN by The amount of rescue medication acetaminophen tablets used by each group during the trial
Time frame: the whole study（16 week）
Evaluate the safety of Y-4 in patients with PHN by The incidence of treatment-emergent adverse events (TEAE) in each group.
Time frame: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by rates of Significant Adverse Events.
Time frame: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by rates of Serious Adverse Events (SAE) after treatment.
Time frame: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by incidence of subject getting abnormal results of vital signs after treatment.
Time frame: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by incidence of subject getting abnormal results of 12-lead ECG after treatment.
Time frame: the whole study(16 week)
Evaluate the safety of Y-4 in patients with PHN by incidence of subject getting abnormal results of laboratory tests after treatment.
Time frame: the whole study (16 week)
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 13 May 2026.
- Individual participant dataSharing planned: No
Related trials for Postherpetic Neuralgia
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
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 Phase 2 study testing Y-4 tables and Pregabalin in people with Postherpetic Neuralgia and Y-4, run by Neurodawn Pharmaceutical Co., Ltd. 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 2 inclusion and 22 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 13 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qianjin Lu (025-85478105, qianlu5860@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: week 13). 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 13 May 2026.