A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate to Severe Central Neuropathic Pain in China
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 408
- 主要终点
- The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline
研究概览
简要总结
To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo.
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
- •Voluntarily sign an informed consent form;
- •Able to read and complete survey questionnaires;
- •Male or female patients aged ≥ 18 years old;
- •The subject has a medical history and symptoms related to central neuropathic pain, including spinal cord related neuropathic pain (subject enrollment ≥ 50%), post-stroke central neuropathic pain, Parkinson's disease pain, and multiple sclerosis pain, and must meet the following criteria: a) pain duration ≥ 3 months; b) Characteristics that conform to neuropathic pain: DN4 scale score ≥ 4 points;
- •During screening visits, patients were assessed to have an average pain visual analogue scale (VAS) score of ≥ 40 mm over the past 24 hours.
排除标准
- •The presence of other painful diseases that may affect the evaluation of neuropathic pain;
- •Patients with spinal cord injury or stroke whose condition is unstable and is expected to require surgical treatment;
- •There is a chronic systemic disease that the investigator has assessed may affect the participant's participation in the study；
- •Meet any of the following laboratory test results: a) Hematology: WBC<3×109/L, N< 1.5 ×109/L, PLT< 75 ×109/L, or HB< 90 g/L; b) Liver function: ALT or AST> 2.5 × ULN; Or TBIL> 1.5 × ULN; c) eGFR< 60 mL/min/1.73 m2; d) Creatine kinase > 2.0 × ULN;
- •Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;
- •Mechanical operators engaged in high-altitude work, motor vehicle driving and other dangerous activities during the study period;
- •Participated in any other clinical study within 30 days prior to screening;
- •The investigator determined that there were other conditions that were not suitable for study participation.
研究组 & 干预措施
HSK16149 20mg-40mg bid
Oral administration of 20mg twice daily for 12 weeks can be adjusted to 40mg twice daily based on the efficacy and tolerability of the subject
干预措施: HSK16149 20mg-40mg BID (Drug)
Placebo
Placebo,Oral,2 capsules, twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline
时间窗: week12
Changes in mean pain intensity (ADPS) at week 12 between HSK16149 and placebo were compared from baseline;The pain NRS score divides a straight line into 10 segments, with 0 to 10 indicating pain (a total of 11 points), 0 indicating no pain, and 10 indicating the most intense pain. The pain NRS scores of the past 7 days were collected and the average value was used as the ADPS score.
次要结局
未报告次要终点