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

Официальное название

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

Обзор

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

Вмешательства

• Препарат HSK16149 20mg-40mg BID
  Oral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy;
• Препарат Placebo
  Placebo, oral, 2 capsules twice daily

Первичные конечные точки

• The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline [Срок оценки: week12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Gou X, Liu Y, Ye Q, He L, Chen Y, Dong Y, Meng Q, Shi Z, Li Y, Lu Y, Wang J, Zeng L. Crisugabalin, a ligand for the alpha2delta subunit of voltage-gated calcium channels, exhibits no obvious abuse potential in rodents. Pharmacol Biochem Behav. 2025 Jul;252:174015. doi: 10.1016/j.pbb.2025.174015. Epub 2025 May 1. PMID 40316144

Идентификаторы

NCT: NCT06422117 · HSK16149-305

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗