Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Location status: Recruiting
NCT Number: NCT07275762
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Nanjing, Jiangsu, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
combination of pregabalin and riluzole
only use pregabalin
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).
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).
Time frame: 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 1-14
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, 3, 5, 7, 11, 13, 14
The items of PGIC are listed as follows Score PGIC
Time frame: week 1, 3, 5, 7, 9, 11, 13, 14
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
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: the whole study(16 week)
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)
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)
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)
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)
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)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
Neurodawn Pharmaceutical Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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