Diabetic Peripheral Neuropathic PainNCT06122012
To Evaluate the Efficacy and Safety of HSK16149 With L-carnitine in Diabetic Peripheral Neuralgia Patients in China
A study testing HSK16149 20mg BID in people with Diabetic Peripheral Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- HSK16149 20mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to May 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign written informed consent;
- Male or female over the age of 18 (including the threshold);
- Diabetic peripheral neuralgia (DPNP) diagnosis;
- The average pain Visual Analogue Scale (VAS) score in the past 24 h was assessed as ≥ 40 mm and < 90 mm during screening.
Who cannot join
- 1. Peripheral neuropathy or pain unrelated to DPN that the investigator determined might confuse the DPNP assessment;
- 2. History of malignant tumors (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening;
- 3. Severe abnormal liver and kidney function, meeting any of the following clinical laboratory test results:
- Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN); Or total bilirubin (TBIL) > 1.5 × ULN;
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (calculated according to simplified MDRD formula);
- 4. Known allergic history to test drug components or other drugs or excipients with similar chemical structure;
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- 5. Past suicidal behavior or suicidal intention;
- 6. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;
- 7. Participated in any other clinical studies within 30 days prior to screening;
- 8. The researcher determines that there are other conditions that are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Fu Liujun, 0379-64922216, Hkdyfyllb@163.com
About this study
Official title: A Study to Evaluate the Efficacy and Safety of HSK16149 Capsule Combined With L-carnitine Hydrochloride Tablets and Lipoic Acid Combined With L-carnitine Hydrochloride Tablets in Diabetic Peripheral Neuralgia Patients in China
Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China
Read the detailed description
Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- HSK16149 20mg BID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK16149 20mg BIDDrug
Also called Lipoic acid tablets 2 tablets BID；L-carnitine hydrochloride tablets 2 tablets TID
HSK16149 20mg BID with L-carnitine hydrochloride tablets 2 tablets TID ；Lipoic acid tablets 2 tablets BID with L-carnitine hydrochloride tablets 2 tablets TID；
| Study group | Role | What they receive |
|---|---|---|
| HSK16149 capsule combined with L-carnitine hydrochloride | Other | HSK16149 capsule (20 mg/ capsule) was administered orally, 1 capsule twice a day for 12 weeks. Acetyl-l-carnitine hydrochloride tablets (0.25g/ tablet) were administered orally after meals, 2 tablets 3 times a day for 12 weeks Receives: Drug: HSK16149 20mg BID |
| Lipoic acid combined with L-carnitine hydrochloride | Other | HSK16149 capsule (20 mg/ capsule) was administered orally, 1 capsule twice a day for 12 weeks. Lipoic acid tablets (0.3g/ tablet) were administered half an hour before breakfast, 2 tablets once a day for 11 weeks. Receives: Drug: HSK16149 20mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy and safety of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablet and lipoic acid combined with acetyl-L-carnitine hydrochloride tablet in the treatment of diabetic peripheral neuralgia
Using the Analysis of Covariance (ANCOVA) model, changes in ADPS relative to baseline at 12 weeks of treatment were taken as dependent variables, and baseline values of study centers, groups, and ADPS were taken as explanatory variables, and the adjusted least squares mean and standard errors of each group were listed. The difference and 95% confidence interval of the mean change of ADPS from baseline at 12 weeks in the HSK16149 capsule combined with acetyl-L-carnitine hydrochloride group compared with the lipoic acid combined with acetyl-L-carnitine hydrochloride group were calculated.
Measured: week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 May 2023
- Primary completion30 Apr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122012
- Sponsor's protocol ID
- HSK16149-206
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fu L, Xu N, Shang J, Yang Q, Li Y, Huang Q, Li J, Jiang H. Crisugabalin Combined with Acetyl-Levo-Carnitine for Diabetic Peripheral Neuropathic Pain: A Phase 2 Randomized Controlled Trial. J Pain Res. 2026 Apr 21;19:588472. doi: 10.2147/JPR.S588472. eCollection 2026.
PubMed 42039234
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of HSK16149 Capsule Combined With L-carnitine Hydrochloride Tablets and Lipoic Acid Combined With L-carnitine Hydrochloride Tablets in Diabetic Peripheral Neuralgia Patients in China
- ClinicalTrials.gov ID
- NCT06122012
- Acronym / sponsor ID
- HSK16149-206
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China
Detailed description
Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK16149 capsule combined with L-carnitine hydrochloride | Other | Drug: HSK16149 20mg BIDHSK16149 capsule (20 mg/ capsule) was administered orally, 1 capsule twice a day for 12 weeks. Acetyl-l-carnitine hydrochloride tablets (0.25g/ tablet) were administered orally after meals, 2 tablets 3 times a day for 12 weeks |
| Lipoic acid combined with L-carnitine hydrochloride | Other | Drug: HSK16149 20mg BIDHSK16149 capsule (20 mg/ capsule) was administered orally, 1 capsule twice a day for 12 weeks. Lipoic acid tablets (0.3g/ tablet) were administered half an hour before breakfast, 2 tablets once a day for 11 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand and voluntarily sign written informed consent;
- Male or female over the age of 18 (including the threshold);
- Diabetic peripheral neuralgia (DPNP) diagnosis;
- The average pain Visual Analogue Scale (VAS) score in the past 24 h was assessed as ≥ 40 mm and < 90 mm during screening.
Key exclusion criteria (10 listed)
- 1. Peripheral neuropathy or pain unrelated to DPN that the investigator determined might confuse the DPNP assessment;
- 2. History of malignant tumors (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening;
- 3. Severe abnormal liver and kidney function, meeting any of the following clinical laboratory test results:
- 4. Known allergic history to test drug components or other drugs or excipients with similar chemical structure;
- 5. Past suicidal behavior or suicidal intention;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK16149 20mg BIDAlso: Lipoic acid tablets 2 tablets BID；L-carnitine hydrochloride tablets 2 tablets TIDHSK16149 20mg BID with L-carnitine hydrochloride tablets 2 tablets TID ；Lipoic acid tablets 2 tablets BID with L-carnitine hydrochloride tablets 2 tablets TID； | Drug | HSK16149 capsule combined with L-carnitine hydrochloride, Lipoic acid combined with L-carnitine hydrochloride |
Primary outcome
To compare the efficacy and safety of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablet and lipoic acid combined with acetyl-L-carnitine hydrochloride tablet in the treatment of diabetic peripheral neuralgia
Time frame: week12
Using the Analysis of Covariance (ANCOVA) model, changes in ADPS relative to baseline at 12 weeks of treatment were taken as dependent variables, and baseline values of study centers, groups, and ADPS were taken as explanatory variables, and the adjusted least squares mean and standard errors of each group were listed. The difference and 95% confidence interval of the mean change of ADPS from baseline at 12 weeks in the HSK16149 capsule combined with acetyl-L-carnitine hydrochloride group compared with the lipoic acid combined with acetyl-L-carnitine hydrochloride group were calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 42039234Fu L, Xu N, Shang J, Yang Q, Li Y, Huang Q, Li J, Jiang H. Crisugabalin Combined with Acetyl-Levo-Carnitine for Diabetic Peripheral Neuropathic Pain: A Phase 2 Randomized Controlled Trial. J Pain Res. 2026 Apr 21;19:588472. doi: 10.2147/JPR.S588472. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HSK16149 20mg BID in people with Diabetic Peripheral Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangqiong Li (+8602867258840, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy and safety of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablet and lipoic acid combined with acetyl-L-carnitine hydrochloride tablet in the treatment of diabetic peripheral neuralgia (time frame: week12). 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 NCT06122012, 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 8 Nov 2023.