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Completed

NCT Number: NCT05890053

To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia

Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia

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Key information

Conditions

Peripheral Neuropathic Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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About this study

Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with Peripheral neuropathic pain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301.
  • Able to understand and voluntarily sign informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

HSK16149 40mg BID

Drug

HSK16149 40mg ， orally twice a day, treatment period; 52-weeks fixed dose.

Other names: HSK16149

Primary outcomes

  1. To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia.

    Time frame: From week 1 to week 53

    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.

Secondary outcomes

  1. Changes in SF-MPQ scores from baseline before and after treatment to evaluate the long-term effectiveness of HSK16149.

    Time frame: From week 1 to week 53

    Based on FAS, descriptive statistical analysis and mapping analysis were performed on the mean values of VAS, PRI and PPI scores and the mean changes from baseline of each visiting point, to compare whether there were statistical differences before and after treatment. Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score:

    Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe) Part 2 - a visual analog scale (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 Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain)

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A 52-week, Open Phase III Study Evaluating the Long-term Safety and Efficacy of HSK16149 Capsules in Chinese Patients With Peripheral Neuralgia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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