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Y-4 to Treat the Postherpetic Neuralgia

NCT07275762 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-13

No results posted yet for this study

Summary

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

  • Postherpetic Neuralgia
  • Y-4
  • Pregabalin

Interventions

DRUG

Y-4 tables

combination of pregabalin and riluzole

DRUG

Pregabalin

only use pregabalin

Sponsors & Collaborators

  • Neurodawn Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2026-07-31
Completion
2026-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07275762 on ClinicalTrials.gov