To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia
A 52-week, Open Phase III Study Evaluating the Long-term Safety and Efficacy of HSK16149 Capsules in Chinese Patients With Peripheral Neuralgia
1 other identifier
interventional
301
1 country
24
Brief Summary
Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2022
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2022
CompletedFirst Submitted
Initial submission to the registry
February 26, 2023
CompletedFirst Posted
Study publicly available on registry
June 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2023
CompletedSeptember 4, 2025
April 1, 2023
1.4 years
February 26, 2023
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia.
Safety assessment variables included AE, ECG, laboratory test values, height and weight, physical examination, and vital signs. Safety data will be summarized by aggregate in SS and all subjects will be listed. Overall description of all AE occurred in subjects by total, and summary of cases, cases and percentage. Clinical judgments of laboratory indicators before and after drug administration (according to the range of normal values or the investigator's judgment of clinical significance) were summarized in the form of crosstabs, and the number and percentage of cases were calculated.
From week 1 to week 53
Secondary Outcomes (1)
Changes in SF-MPQ scores from baseline before and after treatment to evaluate the long-term effectiveness of HSK16149.
From week 1 to week 53
Study Arms (1)
HSK16149 40mg BID
EXPERIMENTALHSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.
Interventions
HSK16149 40mg ， orally twice a day, treatment period; 52-weeks fixed dose.
Eligibility Criteria
You may qualify if:
- Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301.
- Able to understand and voluntarily sign informed consent.
You may not qualify if:
- Medication compliance was \< 80% in double-blind studies.
- In double-blind study, EOT visit (V10) eGFR\< 60 mL/min//1.73m2
- Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study.
- Hepatitis B Surface antigen (HBsAg) positive or hepatitis C virus antibody (HCV Ab) positive during screening \[further hepatitis B virus deoxyribonucleic acid (HBV DNA) titer detection or hepatitis C virus ribonucleic acid (HCV RNA) detection (beyond the detection limit of assay need to be excluded)\], human immunodeficiency virus antibody (HIV) Ab) positive, serum antibody to treponema pallidum (TP Ab) positive (further test for treponema pallidum titer, if positive, excluded).
- Women who are pregnant, planning to become pregnant during the study, or breastfeeding; Participants were not expected to use reliable contraceptive methods (including condoms, spermicides, or intrauterine devices) for 28 days after signing up for the ICF or planning to use progester-containing contraceptives during this period.
- The researcher judged that the study could not be completed according to the scheme or that it was difficult to participate in the study due to safety.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, China
Emergency General Hospital
Beijing, Beijing Municipality, China
The Three Gorges Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
The Third Hospital of Hebei Medical University
Shijiangzhuang, Hebei, China
Kaifeng Hospital of Traditional Chinese Medicine
Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang First People's Hospital
Nanyang, Henan, China
Wuhan Central Hospital
Wuhan, Hubei, China
Nanjing First People's Hospital
Nanjing, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Baotou Central Hospital
Baotou, Neimenggu, China
Jinan Central Hospital
Jinan, Shandong, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Taizhou First People's Hospital
Taizhou, Zhejiang, China
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2023
First Posted
June 6, 2023
Study Start
February 17, 2022
Primary Completion
July 30, 2023
Study Completion
August 7, 2023
Last Updated
September 4, 2025
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share