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

NCT ID: NCT05140863

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-01-05

Brief Summary

Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo

Conditions

Postherpetic Neuralgia

Study Design

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

Study Groups

HSK16149 20mg BID

HSK16149 20mg, orally twice a day for 12 weeks

Group Type: EXPERIMENTAL

HSK16149 20mg BID

Intervention Type: DRUG

HSK16149 20mg, orally twice a day, treatment period; 12-weeks fixed dose

HSK16149 40mg BID

HSK16149 40mg, orally twice a day for 12 weeks

Group Type: EXPERIMENTAL

HSK16149 40mg BID

Intervention Type: DRUG

HSK16149 40mg, orally twice a day, treatment period; 12-weeks fixed dose

Placebo BID

placebo, orally twice a day for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo BID

Intervention Type: DRUG

Placebo, orally twice a day, treatment period; 12-weeks fixed dose

Interventions

HSK16149 20mg BID

HSK16149 20mg, orally twice a day, treatment period; 12-weeks fixed dose

Intervention Type: DRUG

HSK16149 40mg BID

HSK16149 40mg, orally twice a day, treatment period; 12-weeks fixed dose

Intervention Type: DRUG

Placebo BID

Placebo, orally twice a day, treatment period; 12-weeks fixed dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent;

2. Males or females aged 18-75 years of age inclusive;

3. Outpatient, Patients can not stay in the hospital overnight;

4. Patients must have pain present for more than 1 months after the healing of the herpes zoster skin rash;

5. At Screening, pain scale (VAS) of ≥40 mm;

Exclusion Criteria

1. Peripheral neuropathy or pain unrelated to PHN that may confuse the assessment of PHN;

2. Skin conditions in the area affected by neurupathy that could alter sensation;

3. Chronic systemic diseases that may affect subjects' participation in the study;

4. Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:1)Neutrophils < 1.5 × 109/L, or platelet < 90 × 109/L, or hemoglobin < 100 g/L, or 2)AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN, or 3)Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m2, or 4)Creatine kinase > 2.0 × ULN.

5. Uncontrolled diabetes(HbA1c≥11.0% at screening) ;

6. History of substance abuse or alcohol abuse;

7. Any active infections at screening;

8. HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive;

9. Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3);

10. Patients who have undergone neurolytic or neurosurgical therapy 1 week before screening for postherpetic neuralgia;

11. Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of PHN;

12. History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds;

13. History of suicidal behavior or attempted suicide;

14. Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period;

15. Mechanical operators who are engaged in high-altitude operations, motor vehicle driving and other dangerous machinery operators;

16. Participated in another clinical study within 30 days prior to screening;

17. Other conditions unlikely to participate in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatology Hospital of Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Countries

China

References

Zhang D, Lei T, Qin L, Li C, Lin X, Wang H, Zhang G, Zhang S, Shi K, Li L, Yang Z, Yang X, Ba X, Gao Y, Zhang Z, Wang G, Wu L, Wang Y, Wang Y, Zhu S, Shi J, Ye Z, Yang C, Liu C, Zhang T, Lu S, Yu N, Li X, Han X, Chen X, Wan L, Cheng Z, Bai N, Jin Z, Yu C, Zhang W, Lu J, Wang D, Sun H, Wu W, Qin P, Feng Z, Chen R, Zhang T, Yang D, Yin W, Zhang J, Li X, Li F, Wu T, Lu Q. Efficacy and Safety of Crisugabalin (HSK16149) in Adults with Postherpetic Neuralgia: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2024 Nov 1;160(11):1182-1191. doi: 10.1001/jamadermatol.2024.3410.

Reference Type: DERIVED

PMID: 39320907 (View on PubMed)

Other Identifiers

HSK16149-302

Identifier Type: -

Identifier Source: org_study_id