A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2026年8月1日最近更新: 2026年8月11日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 200
试验地点: 1
主要终点: Change in the Average Daily Pain Score (ADPS) from baseline after 12 weeks of administration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial to evaluate the safety, efficacy and pharmacokinetic (PK) profile of HL-1186 Tablet in patients with postherpetic neuralgia (PHN).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Aged ≥ 18 years, of either sex.
•Pain persists for 1 month or more after healing of skin lesions in patients with herpes zoster.
•Participants fully understand the purpose, characteristics, methods of the trial and possible AEs, voluntarily participate in the trial and sign the ICF, or have their legal guardian sign the ICF on their behalf.

排除标准

•Participants with any pain other than PHN, or with other diseases that the researcher considers to potentially affect the evaluation of PHN.
•Participants who may be allergic to the active ingredients or excipients of HL-1186 Tablet, HL-1186 Tablet placebo, pregabalin capsule or pregabalin capsule placebo, have an allergic constitution, or have a history of allergies to ≥ 3 substances.
•Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with PHN.
•The baseline NRS collection begins within the 5 half-lives following the last use of the prohibited drug.
•Participants who have previously used pregabalin with inadequate efficacy or intolerance.
•Clinically significant abnormalities in the 12-lead electrocardiogram (ECG) during the screening period, or complicated with severe cardiopulmonary diseases, which are deemed unsuitable for inclusion by the researcher.
•Participants with a history of malignant tumors within 2 years prior to screening.
•Participants who have undergone major surgery within 8 weeks prior to enrollment or plan to undergo any surgery during the trial period.
•Participants with positive human immunodeficiency virus antibody, positive syphilis serological test, positive hepatitis B virus surface antigen with hepatitis B virus DNA > ULN, or positive hepatitis C virus antibody with hepatitis C virus RNA > ULN.
•Participants with a history of alcoholism or drug abuse within 2 years before screening.
•Female participants who are pregnant, breastfeeding (within 1 year after delivery), or with a positive pregnancy test.
•Participants deemed by the investigator to be unsuitable for participating in this trial for any reason.