Diabetic peripheral neuropathic pain
Conditions
Interventions
Kligabalin Group:Oral test drug
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and voluntarily sign written informed consent; 2. Male or female aged 18~75 years (including the cut-off value); 3. Diagnosis of DPNP based on medical history, physical examination, screening scale DN4 scale score >=4 points and necessary auxiliary examinations; 4. Stable blood glucose control within 3 months before screening, i.e., glycated hemoglobin (HbA1c) =4 points within 1 week of the screening period (i.e., lead-in period), and the pain NRS assessment scale for at least 4 days was filled.
Exclusion criteria
Exclusion criteria: 1. Suffering from peripheral neuropathy or pain unrelated to DPN, which in the opinion of the investigator may confound the assessment of DPNP; 2. Severe hematological, hepatic, and renal function abnormalities, which meet any of the following clinical laboratory test results: 1) Hematology: neutrophils 3 × upper limit of normal (ULN); or total bilirubin (TBIL) >1.5 × ULN; 3) Patients with an estimated glomerular filtration rate (eGFR) 2×ULN; 3. Known history of allergy to the components of the experimental drug or other chemically similar drugs or excipients; 4. If the subject has used a prohibited drug (prohibited drugs/treatments listed in Section 6.3) before screening, the drug must be discontinued for at least 5 half-lives before the screening visit (the specific discontinuation time is subject to the instructions) before screening, and the drug must be discontinued throughout the study period; 5. Those who have had suicidal behavior or suicidal tendencies in the past; 6. Women who are pregnant, preparing to become pregnant during the study, or are breastfeeding; Subjects are unwilling to take reliable contraceptive measures (including condoms, spermicides, or intrauterine devices, etc.) within 28 days from the start of signing the informed consent form to the last dose of the investigational drug, or women who plan to use progesterone-containing contraceptives during this period; 7. Participated in any other clinical study within 30 days before screening; 8. Other conditions judged by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 4 weeks of treatment, the change in the ADPS pain score compared to the baseline level; | — |
Secondary
| Measure | Time frame |
|---|---|
| The relative changes in the ADPS score compared to the baseline during the treatment period, on a weekly basis;During the treatment period, the change in the Daily Sleep Disturbance Score (DSIS) compared to the baseline;During the treatment period, the changes in the symptom scores and the total score of the Simple McGill Pain Questionnaire (SF-MPQ) compared to the baseline were evaluated.;The changes in the Hospital Anxiety and Depression Scale (HADS) scores during the treatment period compared to the baseline scores;index of security;During the treatment period, the change in the score of the health status assessment (EQ-5D-5L) compared to the baseline score;After 4 weeks of treatment, the overall improvement in symptoms such as numbness, pain and abnormal sensations was evaluated in patients using the PGIC scale.; | — |
Countries
China
Contacts
Public ContactXingwu Ran
West China Hospital of Sichuan University
Outcome results
None listed