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

Central Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422117
• Other study ID #: HSK16149-305
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 30, 2024
• Est. completion date: August 7, 2027

Study information

• Verified date: May 2024
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 408
• Est. completion date: August 7, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Voluntarily sign an informed consent form;

2. Able to read and complete survey questionnaires;

3. Male or female patients aged = 18 years old;

4. 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;

5. During screening visits, patients were assessed to have an average pain visual analogue scale (VAS) score of = 40 mm over the past 24 hours.

Exclusion Criteria:

1. The presence of other painful diseases that may affect the evaluation of neuropathic pain;

2. Patients with spinal cord injury or stroke whose condition is unstable and is expected to require surgical treatment;

3. There is a chronic systemic disease that the investigator has assessed may affect the participant's participation in the study;

4. 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;

5. 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;

6. Mechanical operators engaged in high-altitude work, motor vehicle driving and other dangerous activities during the study period;

7. Participated in any other clinical study within 30 days prior to screening;

8. The investigator determined that there were other conditions that were not suitable for study participation.

Related Conditions & MeSH terms

• Central Neuropathic Pain
• Neuralgia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week12