## Protocol Section
### Identification Module
**NCT ID:** NCT06422117

**Brief Title:** Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate and Severe Central Neuropathic Pain in China

**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

#### Organization Study ID Info
**ID:** HSK16149-305
#### Organization
**Class:** INDUSTRY
**Full Name:** Haisco Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-08-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-07-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Haisco Pharmaceutical Group Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Central Neuropathic Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 408

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Drug: HSK16149 20mg-40mg BID

**Label:** HSK16149 20mg-40mg bid

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo,Oral,2 capsules, twice daily for 12 weeks

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HSK16149 20mg-40mg bid

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

**Name:** HSK16149 20mg-40mg BID

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo, oral, 2 capsules twice daily

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline

**Time Frame:** week12

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12381

- Name: Neuralgia

- Relevance: HIGH

- As Found: Neuropathic Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009437

- Term: Neuralgia

### Misc Info Module

- Version Holder: 2024-05-31
