Actively Recruiting
A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-controlled Phase II Study Evaluating Y-4 Tablets Compared With Pregabalin Capsules for Postherpetic Neuralgia
Led by Neurodawn Pharmaceutical Co., Ltd. · Updated on 2026-05-13
160
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a drug called Y-4 for patients with postherpetic neuralgia (PHN), a condition where nerve pain continues after shingles rash has healed. This study compares Y-4 to an existing medication, pregabalin, to see which works better and is safer for managing PHN symptoms. The trial is a phase II, randomized, double-blind study involving Chinese patients with this condition. Participants will receive either Y-4 tablets, which combine pregabalin and riluzole, or pregabalin capsules alone. Both treatments start with a one-week titration period at lower doses, followed by a 12-week fixed-dose period, and end with a one-week drug withdrawal period. They will take the medications twice daily during the 14-week treatment phase after a one-week placebo run-in period. During the study, participants will visit the hospital as scheduled for follow-up assessments. They will be monitored for changes in pain levels, sleep interference, anxiety, and depression using various scales and questionnaires. Researchers will also track the use of rescue medication and record any side effects or abnormal test results over the 16-week study. Participants must use reliable contraception during and one month after the study and report any health changes or new medications to the investigators.
CONDITIONS
Brief 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 the Short-Form McGill Pain Questionnaire of 40 mm or higher during the last 24 hours at screening
You will not qualify if you...
- Known allergy to study drugs, rescue medication ingredients, similar drugs, or excipients
- Diagnosed with peripheral neuropathy or pain unrelated to postherpetic neuralgia that may affect assessment
- Having severe systemic diseases (including serious heart, lung, digestive, neuropsychiatric conditions) that affect participation or evaluation
- History of malignant tumors within 5 years except certain skin or thyroid cancers
- Active infection unsuitable for study entry
- Poorly controlled diabetes (venous blood glucose ≥ 11 mmol/L at screening)
- Immunocompromised diseases or immunosuppressant therapy
- Skin conditions affecting sensation in the affected area
- Recent nerve destruction, nerve blocks, neurostimulation, physical therapy, or acupuncture within 1 week prior to screening
- Use of prohibited drugs within 5 half-lives or dosage changes within 14 days
- Severe blood, liver, or kidney abnormalities based on lab tests
- Diagnosed sleep apnea or severe snoring with daytime sleepiness
- History or risk of suicidal behavior
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Known drug or alcohol abuse within 1 year
- Pregnant or lactating females
- Fertility plans or unwillingness to use reliable contraception during and 1 month after the study
- Participation in another drug clinical trial within 30 days
- Engaging in high-risk activities like high-altitude work or driving during the study
- Other investigator-determined unsuitable conditions for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 weeks
Participants take either Y-4 tablets or pregabalin capsules with a 1-week titration period, 12-week fixed dose period, and 1-week drug withdrawal period.
Weekly visits for up to 14 weeks
Duration - 2 weeks
Participants are monitored for safety and efficacy outcomes after treatment.
1 visit (in-person)
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
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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