Distal Symmetric Polyneuropathy (DSPN)
Conditions
Brief summary
This study aims to evaluate the safety, tolerance, pharmacokinetics/pharmacodynamics and efficacy of SYHA1402 tablets for the treatment of patients with diabetic peripheral neuropathy (DPN) in China.
Detailed description
This is a randomized, multi-center, double-blind, parallel-group, placebo-controlled, phase II clinical trial to evaluate safety, tolerance, pharmacokinetics/pharmacodynamics and efficacy of SYHA1402 tablets in DPN patients. A total number of 135 patients will be randomized (2:2:1) into three groups. Patients between 18 and 75 years old and diagnosed with a Distal Symmetric Polyneuropathy (DSPN) prior to study enrolment will be enrolled. The study consists of 4 stages: a 2-week screening period, a 1-week placebo introduction period, a 16-week randomized double-blind treatment period, and a 2-week post-study follow-up period. The overall planned duration of this study is approximately 21 weeks.
Interventions
DRUGSYHA1402 tablets
SYHA1402 tablets, oral, twice daily
DRUGPlacebo
Placebo, oral, twice daily
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained before any trial-related activities voluntarily, understanding the procedures and methods of this study, and be willing to strictly follow the trial protocol; 2. Males or females, aged 18-75 years (both inclusive); 3. Diagnosed with type 1 or type 2 diabetes for more than 6 months, hemoglobin Alc (HbA1c) between 7% and 10% at screening, fasting plasma glucose (FPG) \<11.1 mmol/L, and the glucose-lowering treatment has been stable for at least 30 days and is expected to remain unchanged throughout the study; 4. According to the 《China Type 2 Diabetes Prevention and Cure Guidelines (2020 edition)》, those diagnosed with diabetic peripheral neuropathy are classified as distal symmetric polyneuropathy (DSPN), the diagnostic criteria consists of:(1) A clear history of diabetes; (2) Neuropathy appeared during or after diagnosis of diabetes; (3) Symptoms and signs are consistent with the performance of DPN; (4) Patients with clinical symptoms (pain, numbness, abnormal sensation, etc.), with abnormality in any 1 of 5 examinations (ankle reflexes, needle pain, vibration, pressure, temperature); Patients without symptoms, with abnormalities in any 2 of 5 examinations and a clinical diagnosis of DPN; (5) Excluding patients with neuropathy caused by other causes; 5. Toronto Clinical Neuropathy Score (TCNS) ≥ 6 points, with sensory test score ≥ 2 points at screening and baseline.
Exclusion criteria
Those who meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS)- Sensory Test Score at week 16 | From baseline to week 16 post-dose | To Compare SYHA1402 with placebo, the overall score and symptom score of mTCNS changes from baseline at week 16. The mTCNS examines signs and symptoms of polyneuropathy. It consists of a questionnaire which explores the presence of foot pain, numbness, tingling, weakness, and loss of sensation leading to ataxia. Secondly, sensory tests will be performed including sensation for pinprick, light touch, temperature, vibration and position sense. The minimum value is 0 meaning the patient does not show any signs or symptoms of polyneuropathy and the maximum value is 33 meaning the patient presents with severe signs and symptoms of polyneuropathy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Toronto Clinical Neuropathy Score (TCNS) at week 16 | From baseline to week 16 post-dose | To Compare SYHA1402 with placebo, the Toronto Clinical Neuropathy Score (TCNS) changes from baseline at week 16. Scales are defined as follows: 0-5 = no neuropathy; 6-8 = mild neuropathy; 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy. |
| Change from baseline in Nerve Conduction Velocities (NCVs) and Amplitude at week 16 | From baseline to week 16 post-dose | To Compare SYHA1402 with placebo, the Nerve Conduction Velocities (NCVs) and Amplitude changes from baseline at week 16. |
| Change from baseline in Visual Analogue Scale (VAS) at week 16 | From baseline to week 16 post-dose | To Compare SYHA1402 with placebo, the Visual Analogue Scale (VAS) changes from baseline at week 16. Including local pain, limb numbness, paresthesia (e.g. burning sensation, formication, electrical sensation). Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain. |
| Change from baseline in the 36-Item Shot-Form Health Survey (SF-36) score at week 16 | From baseline to week 16 post-dose | To Compare SYHA1402 with placebo, the 36-Item Shot-Form Health Survey (SF-36) score changes from baseline at week 16. The SF-36 quality of life scale is used to monitor change in subject reported functionality, well-being, and overall health status. The score of each part ranges from 0 (worst score) to 100 (best score). |
| Change from baseline in overall score and symptom score of mTCNS at week 16 | From baseline to week 16 post-dose | To Compare SYHA1402 with placebo, the overall score and symptom score of mTCNS changes from baseline at week 16. The mTCNS examines signs and symptoms of polyneuropathy. It consists of a questionnaire which explores the presence of foot pain, numbness, tingling, weakness, and loss of sensation leading to ataxia. Secondly, sensory tests will be performed including sensation for pinprick, light touch, temperature, vibration and position sense. The minimum value is 0 meaning the patient does not show any signs or symptoms of polyneuropathy and the maximum value is 33 meaning the patient presents with severe signs and symptoms of polyneuropathy. |
| Volume of Distribution (V) | Pre-dose and multiple timepoints up to 16 weeks | Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Volume of Distribution |
| Pharmacodynamics (PD) indicator | Pre-dose and multiple timepoints up to 16 weeks | Proportional change from baseline in whole blood/red blood cell sorbitol concentration (%) |
| Incidence of adverse events (AEs) | Throughout the study period, an average of 21 weeks | Incidence of adverse events (AEs) |
| Clearance (CL) | Pre-dose and multiple timepoints up to 16 weeks | Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Clearance |
Contacts
Primary ContactXinhua Xiao, Professor
Outcome results
None listed