Actively Recruiting
Y-4 to Treat the Postherpetic Neuralgia
Led by Neurodawn Pharmaceutical Co., Ltd. · Updated on 2026-05-13
160
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Y-4 to Treat the Postherpetic Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Age 18 years or older, any gender
- Diagnosed with postherpetic neuralgia with pain lasting more than one month after shingles rash healed
- Visual Analog Scale (VAS) score in Short-Form McGill Pain Questionnaire (SF-MPQ) of 40 mm or higher during the last 24 hours at screening
You will not qualify if you...
- Known allergy to investigational products, rescue medications, chemically similar drugs, or excipients
- Diagnosed with peripheral neuropathy or pain unrelated to PHN that could affect assessment
- Severe cardiopulmonary diseases, chronic digestive diseases, neuropsychiatric disorders, recent cerebrovascular events, or recent malignant tumors
- Active infection or immunocompromised conditions
- Skin conditions affecting sensation on the affected area
- Recent nerve destruction treatments or physical therapies for PHN within one week
- Use of prohibited drugs within first 5 half-lives or dosage changes within 14 days
- Severe blood, liver, or kidney function abnormalities
- Diagnosed sleep apnea, severe snoring with daytime sleepiness, or intermittent hypoxia
- History of suicidal behavior or tendencies
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Known drug or alcohol abuse within one year
- Pregnant or lactating females
- Fertility plans or unwillingness to use non-drug contraceptive methods during study and one month after
- Participation in other drug clinical trials within 30 days
- Engaging in high-risk activities like high-altitude work or operating heavy machinery during study
- Other conditions judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
Q
Qianjin Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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