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

NCT05140863 | Completed Phase 3

• 1 other identifier: HSK16149-302
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Compare the change from baseline in ADPS between HSK16149 and placebo at week 12

  The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries

  Baseline and week 12

Secondary Outcomes (10)

• Compare the response rate between HSK16149 and placebo at week 12 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline )

  Baseline and week 12

• Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 12

  From week 1 to week 12

• Compare the change from baseline in Visual Analogue Scale（VAS） between HSK16149 and placebo at week 12

  Baseline and week 12

• Compare the change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 12

  Baseline and week 12

• Compare the change from baseline in Average Daily Sleep interference score（ADSIS） between HSK16149 and placebo at week 12

  Baseline and week 12

Study Arms (3)

HSK16149 20mg BID

EXPERIMENTAL

HSK16149 20mg, orally twice a day for 12 weeks

Drug: HSK16149 20mg BID

HSK16149 40mg BID

EXPERIMENTAL

HSK16149 40mg, orally twice a day for 12 weeks

Drug: HSK16149 40mg BID

Placebo BID

PLACEBO COMPARATOR

placebo, orally twice a day for 12 weeks

Drug: Placebo BID

Interventions

HSK16149 20mg BID DRUG

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

HSK16149 20mg BID

HSK16149 40mg BID DRUG

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

HSK16149 40mg BID

Placebo BID DRUG

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

Placebo BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Males or females aged 18-75 years of age inclusive;
• Outpatient, Patients can not stay in the hospital overnight;
• Patients must have pain present for more than 1 months after the healing of the herpes zoster skin rash;
• At Screening, pain scale (VAS) of ≥40 mm;

You may not qualify if:

• Peripheral neuropathy or pain unrelated to PHN that may confuse the assessment of PHN;
• Skin conditions in the area affected by neurupathy that could alter sensation;
• Chronic systemic diseases that may affect subjects' participation in the study;
• 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.
• Uncontrolled diabetes(HbA1c≥11.0% at screening) ;
• History of substance abuse or alcohol abuse;
• Any active infections at screening;
• HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive;
• Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3);
• Patients who have undergone neurolytic or neurosurgical therapy 1 week before screening for postherpetic neuralgia;
• Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of PHN;
• History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds;
• History of suicidal behavior or attempted suicide;
• 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;
• Mechanical operators who are engaged in high-altitude operations, motor vehicle driving and other dangerous machinery operators;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Dermatology Hospital of Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210042, China

Location

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (1)

• 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.

  PMID: 39320907 DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: December 2, 2021
• Study Start: November 1, 2021
• Primary Completion: December 22, 2022
• Study Completion: January 5, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

CN (2)