> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/to-evaluate-the-efficacy-and-safety-of-hsk16149-capsule-in-74a4101e-389a-48b3-94c1-5663e1caa5c2
> Record changed: 2026-10-13

# To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia

NCT05763550

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

Participants

331

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

Start date

2023-02-27

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Title and summary

**Summary**

Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Short title**

To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Official title**

A Multicenter, Randomized, Double-Blind, Double-Dummy , Pregaballin-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Herpetic Neuralgia

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Dates

**Completion date**

2023-08-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**First posted**

2023-03-10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Registry last updated**

2023-11-08

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Primary completion date**

2023-06-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Start date**

2023-02-27

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Size and sites

**Actual participants**

331

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Participants**

331

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Protocol amendments**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Lead sponsor**

Haisco Pharmaceutical Group Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Identifiers

**Registry ID**

NCT05763550

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**ClinicalTrials.gov ID**

NCT05763550

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Outcomes

### Primary outcomes

1. Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4  
Timeframe: Baseline and week 4  
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\\\[no pain\\\] to 10 \\\[worst possible pain\\\]

### Secondary outcomes

1. Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )  
Timeframe: Baseline and week 4
2. Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4  
Timeframe: Baseline and week 4  
VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain
3. Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4  
Timeframe: Baseline and week 4  
The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

- Signed informed consent;
- Males or females aged 18 years and older ;
- Patients must have herpetic neuralgia;
- At Screening, pain scale (VAS) of ≥ 40 mm;
- At Screening, pain scale (NRS) of ≥ 4.

### Exclusion criteria

- Patients have pain present for more than 1 months after the healing of the herpes zoster skin rash;
- AST/ALT > 2 × upper limit of normal (ULN), or TBIL≥1.5 × ULN;
- Serum Creatine > 176μmol/L;
- Any active infections at screening;
- History of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds;
- Participated in another clinical study within 30 days prior to screening;
- Pregnant or breastfeeding at screening ;
- Other conditions unlikely to participate in this trial.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Sites

- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763550)

## Related records

### Drugs (2)

- [Crisugabalin](https://trialight.com/data/asset/crisugabalin-1a727ec1-0255-424a-9825-3596702fd2da.md)
- [Pregabalin](https://trialight.com/data/asset/pregabalin-c76529d4-1815-46a3-954e-cf21d394857b.md)

### Lead sponsors (1)

- [Haisco Pharmaceutical Group Co., Ltd.](https://trialight.com/data/company/haisco-pharmaceutical-group-co-ltd-152e9539-c5d9-41ff-80ac-cc890e779031.md)

### Targets (26)

- [CACNA1A](https://trialight.com/data/target/cacna1a-f3f512f5-11c9-5ce1-9657-c0382bc52e15.md)
- [CACNA1B](https://trialight.com/data/target/cacna1b-24763181-bb0a-5937-9a02-22235ff3bb78.md)
- [CACNA1C](https://trialight.com/data/target/cacna1c-744d59ab-a8de-5b82-a952-b270470e3b23.md)
- [CACNA1D](https://trialight.com/data/target/cacna1d-b08698ee-d3e0-5823-b979-0629beace3ff.md)
- [CACNA1E](https://trialight.com/data/target/cacna1e-c508fca1-41b4-5369-b279-6761696196ec.md)
- [CACNA1F](https://trialight.com/data/target/cacna1f-460ea1ea-3439-556a-8977-c71a6caae1bc.md)
- [CACNA1G](https://trialight.com/data/target/cacna1g-72e1e321-69cf-537b-8c11-788ba63b4dd9.md)
- [CACNA1H](https://trialight.com/data/target/cacna1h-595ec1a8-0caa-50c4-aeb4-988ee9ca4795.md)
- [CACNA1I](https://trialight.com/data/target/cacna1i-ce34754d-0161-5c89-91d2-f30f31cce88d.md)
- [CACNA1S](https://trialight.com/data/target/cacna1s-323f267a-8656-5845-a35c-8ccdc4d6896d.md)
- [CACNA2D1](https://trialight.com/data/target/cacna2d1-8eefc789-f466-5eb7-a36d-39cab2dfa291.md)
- [CACNA2D2](https://trialight.com/data/target/cacna2d2-e376fbe9-7b23-50f6-8c0a-4b12f685aba7.md)
- [CACNA2D3](https://trialight.com/data/target/cacna2d3-8559580c-10bc-5be0-9aa8-e0dd4a4ee704.md)
- [CACNA2D4](https://trialight.com/data/target/cacna2d4-8a088ee2-4342-5d94-95c0-484844272bf1.md)
- [CACNB1](https://trialight.com/data/target/cacnb1-73393fc2-c12d-5f4e-90de-ce8e0898c9dd.md)
- [CACNB2](https://trialight.com/data/target/cacnb2-0b297a77-ce96-5d3b-a11b-cbf3d5a7090d.md)
- [CACNB3](https://trialight.com/data/target/cacnb3-2c6499a0-ccf7-50e9-9d89-2376ae8f73e6.md)
- [CACNB4](https://trialight.com/data/target/cacnb4-39e0edca-ff11-5ce2-afed-c8ee92399ad0.md)
- [CACNG1](https://trialight.com/data/target/cacng1-1c93a084-9dab-58d5-8a45-88f97a7a2151.md)
- [CACNG2](https://trialight.com/data/target/cacng2-f4814c27-29be-5fd3-b70c-e2d6696dc253.md)

---

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