Y-4 to Treat the Postherpetic Neuralgia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeurodawn Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
1. Known previous allergy to the investigational products, rescue medication ingredients, other chemically similar drugs, or excipients.
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Y-4 tables
Drugcombination of pregabalin and riluzole
Pregabalin
Drugonly use pregabalin
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Y-4 groupExperimental treatment 1 intervention
Group B: pregabalin groupOther 1 intervention
Trial outcomes
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).
Time frame
week 13Secondary outcomes
1
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 132
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 143
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 1-144
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, 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov