Evaluating HSK16149 and L-carnitine for diabetic nerve pain in China

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

This study is testing if a new combination of HSK16149 capsules and L-carnitine can help people in China with diabetic nerve pain feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (industry)
• Locations: 1 site (Luoyang, Henan)
• Trial ID: NCT06122012 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of HSK16149 capsules combined with acetyl-L-carnitine hydrochloride tablets in patients suffering from diabetic peripheral neuropathic pain (DPNP) in China. Participants will be assessed based on their pain levels using a Visual Analogue Scale (VAS) during the screening process. The study aims to determine whether this combination therapy can effectively alleviate pain associated with DPNP. The trial will involve monitoring participants for any adverse effects and overall treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with diabetic peripheral neuralgia and experiencing moderate to severe pain.

Not a fit: Patients with peripheral neuropathy unrelated to diabetes or those with severe liver or kidney dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients with diabetic peripheral neuropathic pain.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches using L-carnitine for neuropathic pain have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Able to understand and voluntarily sign written informed consent;
2. Male or female over the age of 18 (including the threshold);
3. Diabetic peripheral neuralgia (DPNP) diagnosis;
4. The average pain Visual Analogue Scale (VAS) score in the past 24 h was assessed as ≥ 40 mm and \< 90 mm during screening.

Exclusion Criteria:

* 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:
  1. Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN); Or total bilirubin (TBIL) \> 1.5 × ULN;
  2. 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;

  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.

Where this trial is running

Luoyang, Henan

• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (RECRUITING)

Study contacts

• Study coordinator: Fangqiong Li

Conditions: Diabetic Peripheral Neuropathic Pain