Recruiting PHASE2 Postherpetic Neuralgia

New treatment option for Postherpetic Neuralgia

Official title Y-4 to Treat the Postherpetic Neuralgia

ClinicalTrials.gov ID: NCT07275762

What this study is testing

What is Y-4 tables?

Y-4 tables is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for postherpetic neuralgia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • \- 1. Able to understand and voluntarily sign the informed consent form. 2. Age ≥ 18 years, any gender. 3. Diagnosed with PHN, meaning pain persists...
  • 4\. VAS score in SF-MPQ ≥ 40 mm of the last 24 hours during screening.

You likely can't join if

  • 1\. Known previous allergy to the investigational products, rescue medication ingredients, other chemically similar drugs, or excipients. 2\. During...
  • Severe cardiopulmonary diseases, such as unstable angina, myocardial infarction, severe arrhythmia within 6 months prior to screening, NYHA cardiac...
  • 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...
  • History of malignant tumors within 5 years prior to screening (excluding cured basal cell carcinoma of the skin, carcinoma in situ and papillary...
  • Presence of active infection, which, in the opinion of the investigator, is not suitable for entry into this study;
See the full eligibility criteria
Who can join
  • \- 1. Able to understand and voluntarily sign the informed consent form. 2. Age ≥ 18 years, any gender. 3. Diagnosed with PHN, meaning pain persists for more than one month after the acute shingles rash has healed.
  • 4\. VAS score in SF-MPQ ≥ 40 mm of the last 24 hours during screening.
What rules you out
  • 1\. Known previous allergy to the investigational products, rescue medication ingredients, other chemically similar drugs, or excipients. 2\. During screening, individuals who have been clearly diagnosed with peripheral...
  • 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...
  • 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...
  • History of malignant tumors within 5 years prior to screening (excluding cured basal cell carcinoma of the skin, carcinoma in situ and papillary thyroid carcinoma);
  • Presence of active infection, which, in the opinion of the investigator, is not suitable for entry into this study;
  • Diabetic patients with poor glycemic control (peritoneal venous blood glucose ≥11mmol/L at screening);
  • Suffering from immunocompromised diseases, such as systemic lupus erythematosus, acquired immunodeficiency syndrome, immunosuppressant therapy for autoimmune diseases. 4\. During screening, situations may exist that...

The study team makes the final eligibility decision.

Where it's taking place

  • Nanjing, Jiangsu, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.