A Phase 2 interventional study of Y-4 tables and Pregabalin in Postherpetic Neuralgia, Y-4 and Pregabalin, sponsored by Neurodawn Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Neurodawn Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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 :
196 studies on the registry are indexed under Neuralgia, Postherpetic; 28 are open to participants now.
This study's planned enrollment of 160 is above the median of 94 across 162 interventional studies indexed under Neuralgia, Postherpetic.
Browse Neuralgia, Postherpetic studies →Neurodawn Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 1. Able to understand and voluntarily sign the 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 products, rescue medication ingredients, other chemically similar drugs, or .
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.
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: \< 1.5×109/L, or \< 90×109/L, or \<100g/L; 2) Liver function: or AST > 2.5 times ; or > 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. surface antigen (HBsAg) positive and HBV-DNA titer >lower limit of reference value, or virus antibody (HCV-Ab) positive and HCV-DNA titer >lower limit of reference value, or 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Y-4 tables
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.
Drug: Pregabalin
combination of pregabalin and riluzole
only use pregabalin
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).
Time frame: week 13
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).
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.
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).
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;
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)
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.
The items of PGIC are listed as follows Score PGIC 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Worse 6. Much worse 7. Very much worse
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);
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)
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
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.
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
4-6 h per time, The maximum daily dose should not exceed 2.0 g, and continuous use should not exceed 5 days.
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.
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.
Time frame: 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.
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.
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.
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.
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).
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.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation
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.
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.
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.
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.
Time frame: the whole study (16 week)
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Jul 2026, 5 months after the start.
Of 12 phase 2 interventional studies under Neuralgia, Postherpetic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 17. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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