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Peripheral Neuropathic PainPhase 3NCT05890053

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

A Phase 3 study testing HSK16149 40mg BID in people with Peripheral Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 24 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Peripheral Neuropathic Pain
What is being tested?
HSK16149 40mg BID
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
24 sitesChina
Study dates
17 Feb 2022to 7 Aug 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Baotou Central Hospital

    Baotou, Neimenggu

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Pinggu District Hospital

    Beijing, Beijing Municipality

  • Emergency General Hospital

    Beijing, Beijing Municipality

  • Cangzhou People's Hospital

    Cangzhou, Hebei

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Three Gorges Hospital Affiliated to Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Jinan Central Hospital

    Jinan, Shandong

  • Kaifeng Hospital of Traditional Chinese Medicine

    Kaifeng, Henan

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Nanjing First People's Hospital

    Nanjing, Jiangsu

  • Nanyang First People's Hospital

    Nanyang, Henan

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • The Third Hospital of Hebei Medical University

    Shijiangzhuang, Hebei

  • Taizhou First People's Hospital

    Taizhou, Zhejiang

  • Wuhan Central Hospital

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi'an Medical University

    Xi’an, Shanxi

  • The Second People's Hospital of Yibin

    Yibin, Sichuan

  • Yuncheng Central Hospital

    Yuncheng, Shanxi

Other trials in China

About this study

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

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

Read the detailed description

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

Being tested
HSK16149 40mg BID

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK16149 40mg BIDDrug

    Also called HSK16149

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

Study groups in NCT05890053
Study groupRoleWhat they receive
HSK16149 40mg BIDExperimentalHSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.
Receives: Drug: HSK16149 40mg BID

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From week 1 to week 53

Secondary outcomes (1)

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

    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)

    Measured: From week 1 to week 53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start17 Feb 2022
  3. Primary completion30 Jul 2023
  4. Study completion7 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890053
Sponsor's protocol ID
HSK16149-303
Status last verified
Apr 2023
First submitted
26 Feb 2023
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo X, Wang K, Zhang T, Ma J, Li Y, Jiang C, Liu J, Zhang Y, Bian F, Zhang F, Liu W, Wu X, Tang X, Wang Y, Ning T, Pang S, Li Y, Wang L, Sun J, Hu H, Mao H, Pan T, Li Y, Sun X, Li P, Li F, Huang Q, Li Y. Long-Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52-Week, Multicenter, Single-Arm Trial. J Diabetes Res. 2026;2026(1):e2960736. doi: 10.1155/jdr/2960736.

    PubMed 41871187

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HSK16149 40mg BID in people with Peripheral Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia. (time frame: From week 1 to week 53). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05890053, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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