None listed
Conditions
Interventions
Drug : [Placebo Group]
Take two placebo capsules for 4 weeks.
[VVZ-2471 100mg Group]
Take VVZ-2471 100mg of the drug twice daily for 4 weeks.
[VVZ-2471 150mg Group]
Take VVZ-2471 100mg of the drug twi
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who voluntarily sign the informed consent form before participation, understand the study objectives and procedures, and are able to complete the subject diary. 2. Male or female subjects aged between 19 and 80 years. 3. For female subjects: Must be non-childbearing (e.g., surgically sterile via tubal ligation, hysterectomy, or oophorectomy) or postmenopausal (=1 year without menstruation, age =50). For male subjects: Must be sterile (vasectomy) or agree to abstain from sexual activity or use medically accepted contraception from screening until 14 days after the last dose. Additionally, must not intend to donate sperm within 100 days post-study (acceptable contraception methods include condoms, the female partner using an oral contraceptive for =3 months, injectable or implantable contraception, or an intrauterine device). 4. Postherpetic Neuralgia patients who have experienced persistent pain for at least 3 months after herpetic rash onset and have received treatment for at least 1 month (documented via a medical referral letter or equivalent). 5. Subjects with a pain intensity score(VAS,Visual Analogue Scale pain intensity) of =4 on the pain assessment at screening. 6. Subjects with a VAS(Visual Analogue Scale pain intensity) pain score of 4 or higher at randomization
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding, or potentially pregnant women. 2. Subjects with a VAS(Visual Analogue Scale pain intensity) pain score exceeding 9 at screening. 3. Subjects with a VAS(Visual Analogue Scale pain intensity) pain score exceeding 9 at randomization. 4. Subjects with the following history related to the target Postherpetic Neuralgia condition: - Subjects who have undergone neurolytic procedures (e.g., using phenol or ethyl alcohol) - Subjects who have received a nerve block using a local anesthetic within 2 weeks - Subjects who have received a steroid nerve block within 1 month. - Subjects who have undergone pulsed radiofrequency thermocoagulation within 1 month. - Subjects who have undergone conventional radiofrequency thermocoagulation within 1 month. 5. Subjects with other pain conditions that could affect Postherpetic Neuralgia assessment. 6. Subjects with neuropathic pain conditions other than Postherpetic Neuralgia. 7. Subjects who have initiated or changed the dose of prohibited concomitant medications within 14 days prior to the first administration of the investigational medicinal product. 8. Subjects with gastrointestinal disorders that could affect drug absorption. 9. Subjects with a history of malignant tumors (except basal cell carcinoma) within 2 years prior to screening. 10. Subjects diagnosed with clinically significant neurological, ophthalmologic, hepatobiliary, respiratory, or hematologic diseases within 1 year before screening, or those with a history of cardiovascular diseases such as severe hypotension, uncontrolled arrhythmia, or myocardial infarction. 11. Subjects with a history of pernicious anemia, untreated hypothyroidism, or HIV infection. 12. Subjects who test positive for HBs-Ag or Anti-HCV Ab in serum screening. 13. Subjects with immune-compromised conditions (e.g., systemic lupus erythematosus, acquired immunodeficiency syndrome, or those taking immunosuppressants for autoimmune diseases). 14. Diabetic patients (fasting blood glucose =128 mg/dL or HbA1c =6.5%), those with a history of diabetes, or those taking antidiabetic medications (except those with stable glycemic control). 15. Subjects with major psychiatric disorders. 16. Subjects with a history of drug or alcohol abuse within 1 year before screening. 17. Subjects with ECG findings at screening or randomization of QTcF(Corrected QT interval) > 450ms(male) or QTcF(Corrected QT interval) > 470ms(female), PR(PR interval) interval > 210 ms, or QRS(QRS complex interval) interval > 120 ms, or any other clinically significant ECG abnormalities. 18. Subjects deemed unsuitable for the study by the investigator or study personnel. 19. Subjects who have received another investigational product within 30 days before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity (VAS): Day 1 pre-dose – Week 4 last 3 days average;Responder rate: Proportion of subjects with =20%, =30%, or =40% reduction in the average pain intensity (VAS) during the last 3 days of Week 4 compared to Day 1 pre-dose.;Difference in VAS pain intensity between Day1 and Day28;Changes in pain intensity and sleep disturbance scores: Mean changes during the last 3 days of each week over the 4-week treatment period.;Proportion of patients and amount of use for 1st-, 2nd-, and 3rd-line rescue medications and their total: Weekly changes over the 4-week treatment period.;Overall patient evaluation of pain relief | — |
Secondary
| Measure | Time frame |
|---|---|
| Dropout rate after initiating investigational product administration;Changes in pain assessment scores at Day 1, Day 8, Day 15, and Day 28;Pharmacokinetic evaluation of VVZ-2471 capsule formulation;Evaluation based on adverse events, clinical laboratory tests (hematology, blood chemistry, coagulation tests), vital signs, physical examination, and 12-lead ECG results;Subgroup Analysis of the Primary Endpoint by Dosing Condition (Fasted/Fed) | — |
Countries
Korea, Republic of
Contacts
Public ContactHue Jung Park
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed