Clinical trial NCT05140863: To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week, Phase 3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postherpetic Neuralgia
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Compare the change from baseline in ADPS between HSK16149 and placebo at week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Compare the response rate between HSK16149 and placebo at week 12 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline )
timeFrame: Baseline and week 12
measure: Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 12
timeFrame: From week 1 to week 12
measure: Compare the change from baseline in Visual Analogue Scale（VAS） between HSK16149 and placebo at week 12
timeFrame: Baseline and week 12
measure: Compare the change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 12
timeFrame: Baseline and week 12
measure: Compare the change from baseline in Average Daily Sleep interference score（ADSIS） between HSK16149 and placebo at week 12
timeFrame: Baseline and week 12
measure: Compare the total consumption of Acetaminophen and Paracetamol and Dihydrocodeine Tartrate between HSK16149 and placebo during the trial
timeFrame: From week 1 to week 12
measure: Compare the change from baseline in EQ-5D-5L between HSK16149 and placebo at week 12
timeFrame: Baseline and week 12
measure: AE（adverse event） to evaluate the safety of HSK16149 during the trial
timeFrame: From week 1 to week 12
measure: Peak Plasma Concentration (Cmax) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia
timeFrame: Week 4,week 8,week 10,week 12
measure: Area under the plasma concentration versus time curve (AUC) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia
timeFrame: Week 4,week 8,week 10,week 12
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Dermatology Hospital of Chinese Academy of Medical Sciences
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital Of Nanchang University
state: Jiangxi
Study officials:
References: