To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo.
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;
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;
Parallel
HSK16149 20mg-40mg BID
DrugOral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy;
Placebo
DrugPlacebo, oral, 2 capsules twice daily
The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline
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.
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