Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate and Severe Central Neuropathic Pain in China

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • HSK16149 20mg-40mg BID
  • Placebo

Treatment groups

408 Participants
are divided into 2 treatment groups

Locations

This trial has no locations