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

NCT ID: NCT06422117

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2027-08-07

Brief Summary

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

Conditions

Central Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

HSK16149 20mg-40mg BID

Intervention Type: DRUG

Oral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy;

Placebo

Placebo,Oral,2 capsules, twice daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, oral, 2 capsules twice daily

Interventions

HSK16149 20mg-40mg BID

Oral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy;

Intervention Type: DRUG

Placebo

Placebo, oral, 2 capsules twice daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HSK16149-305

Identifier Type: -

Identifier Source: org_study_id