Distal Symmetric Polyneuropathy (DSPN)Phase 2NCT05116111
A Study To Evaluate the Safety, Tolerance, Pharmacokinetics/Pharmacodynamics and Efficacy of SYHA1402 Tablets For the Treatment of Patients With Diabetic Peripheral Neuropathy in China
A Phase 2 study testing SYHA1402 tablets in people with Distal Symmetric Polyneuropathy (DSPN), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Distal Symmetric Polyneuropathy (DSPN)
- What is being tested?
- SYHA1402 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 15 Jun 2023
- Phase
- Phase 2
- 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
- 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;
- Males or females, aged 18-75 years (both inclusive);
- 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;
- 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;
- Toronto Clinical Neuropathy Score (TCNS) ≥ 6 points, with sensory test score ≥ 2 points at screening and baseline.
Who cannot join
- Those who meet any of the exclusion criteria will not be enrolled:
- Patients with peripheral neuropathy caused by other diseases: such as cervical and lumbar vertebral disease, cerebrovascular disease, intracranial tumor or trauma, toxic peripheral neuropathy (e.g. chemotherapy, alcohol), Guillain-Barr é syndrome, multiple sclerosis, bone joints or tendon lesions, severe arteriovenous and vascular lesions, severe liver and kidney insufficiency, hyperthyroidism or degeneration, subclinical thyroid dysfunction, vitamin B12 deficiency, infection (e.g. human immunodeficiency virus), etc;
- Patients with previous peripheral arterial disease, and significant intermittent claudication symptoms or previous lower extremity vascular bypass or angioplasty at screening;
- History of malignant neoplasms (except cured basal cell skin cancer, in-situ carcinomas and papillary thyroid cancer) or history of antineoplastic therapy within 5 years prior to screening;
- Patients with a change of more than 2 points in the same item of the mTCNS at screening and baseline;
- Visual Analogue Scale (VAS) > 8 points at screening;
Show all 28Show fewer
- Diabetic foot, diabetic peripheral vascular lesions, lower limb amputation, diabetic muscular atrophy, Charcot joint disease within 3 months prior to screening;
- Acute complications such as severe hypoglycemia with loss of consciousness, diabetic ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome, lactic acidosis, etc. within 3 months prior to screening;
- Those who have used a prohibited combination drug within 3 months before screening must discontinue the drug for at least 1 month or 5 half-lives (whichever is longer) prior to screening visit, and the drug must be discontinued throughout the study period;
- Any of the following cardiovascular events within 6 months prior to screening: unstable angina requiring hospitalization, myocardial infarction, coronary artery bypass transplantation, transdermal coronary intervention (diagnostic angiography is permitted), moderate to severe congestive heart failure (NYHA III or IV), atrial or ventricular arrhythmia (e.g. atrial fibrillation, ventricular tachycardia, etc.) requiring hospitalization, pacemaker or defibrillator implantation, temporary cerebral ischemic attacks or cerebrovascular accidents (e.g. strokes); Or coronary artery bypass grafting or revascularization is planned during the study;
- Uncontrolled severe hypertension (untreated or post-treated) at screening, defined as systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg;
- Those who with awake pulse < 60 BPM or > 100 BPM at screening；
- The Body Mass Index (BMI) < 18.5 kg/m^2 or > 35 kg/m^2 at screening, calculated by BMI = body weight (kg)/height^2(m^2);
- Grade II or III atrioventricular block occurred in 12-lead ECG (in the absence of a pacemaker) at screening, long QT syndrome or QTc > 450 ms (male) / 470 ms (female);
- Any active infections at screening, including but not limited to urinary tract infections, upper respiratory tract infections, diabetic foot infections, etc., and who needs further treatment;
- Severe hematologic, hepatic, or renal abnormalities at screening with any laboratory assessments meeting the following criteria: 1)Platelet count < 100 × 10^9/L; 2) Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 × upper limit of normal (ULN) of the reference range, or total bilirubin ≥ 1.5 × ULN of the reference range; 3) Creatine kinase > 2.0 × ULN; 4) Estimated renal glomerular Filtration Rate (eGFR) < 60 mL/(min*1.73m^2) (calculated using the CKD-EPI formula); 5) Triglycerides (TG) > 5.6 mmol/L;
- HBsAg-positive with HBV DNA copy number above the lower limit of the HBV DNA test, or HCV antibodies (HCV Ab)-positive with HCV RNA copy number above the lower limit of the HCV RNA test, human immunodeficiency virus antibody (HIV Ab) positive, serum syphilis helix antibody (TP Ab) positive with syphilis helix titrating positive at screening;
- Thyroid dysfunction (FT3, FT4, TSH examination with clinically significant abnormalities) at screening, including undergoing treatment;
- Cannot swallow oral drugs, or suffer from diseases that affect oral drug absorption, distribution, metabolism, excretion, as well as diseases that affect the evaluation of the efficacy and safety of experimental drugs, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc;
- Patients who are allergic to any ingredient in the test drug;
- Patients with severe bleeding disorders;
- Conditions that may affect the evaluation of efficacy, such as skin diseases in the affected skin area that may affect the evaluation of nerve conduction function;
- Pregnancy, breast-feeding, the intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male patient do not wish to use adequate contraceptive measures from the time signing the informed consent form until 3 months after the last dose of the study drug;
- Patients who have a history of alcohol addiction or substance abuse prior to screening (alcohol addiction is defined as regular daily alcohol consumption in excess of the following standard amounts: 720 mL of beer, 300 mL of red wine or 90 mL of liquor, approximately 20 g of alcohol) or an inability to limit alcohol consumption to this standard throughout the study period;
- Patients who have smoked more than 10 cigarettes (including 10 cigarettes) per day in the three months before screening or who could not control less than 10 cigarettes per day during the whole study period;
- Participation in other trials within 3 months prior to screening;
- Risk of incompliance and/or inability to complete the trial, as judged by the investigator, including but not limited to: psychiatric disorder (such as eating disorder), mental incapacity, unwillingness or evidence of uncooperative attitude, language barriers precluding adequate understanding of the trial (including inability to read or write);
- Patient compliance < 80% or > 120% during the introductory period.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Multi-center, Double-blind, Parallel-group, Placebo-controlled Phase II Study To Evaluate the Safety, Tolerance, Pharmacokinetics/Pharmacodynamics and Efficacy of SYHA1402 Tablets For the Treatment of Patients With Diabetic Peripheral Neuropathy in China
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.
Read the 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.
- Conditions
- Distal Symmetric Polyneuropathy (DSPN)
- Being tested
- SYHA1402 tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHA1402 tabletsDrug
SYHA1402 tablets, oral, twice daily
PlaceboDrug
Placebo, oral, twice daily
| Study group | Role | What they receive |
|---|---|---|
| SYHA1402 1000 mg plus placebo 500 mg | Experimental | Eligible patients will be randomly assigned to receive SYHA1402 1000 mg and placebo 500 mg twice daily for 16 weeks of treatment after a placebo introduction period. Receives: Drug: SYHA1402 tablets; Drug: Placebo |
| SYHA1402 1500 mg | Experimental | Eligible patients will be randomly assigned to receive SYHA1402 1500 mg twice daily for 16 weeks of treatment after a placebo introduction period. Receives: Drug: SYHA1402 tablets |
| Placebo 1500 mg | Placebo comparator | Eligible patients will be randomly assigned to receive placebo 1500 mg twice daily for 16 weeks of treatment after a placebo introduction period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS)- Sensory Test Score at week 16
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.
Measured: From baseline to week 16 post-dose
Secondary outcomes (9)
Change from baseline in overall score and symptom score of mTCNS at week 16
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.
Measured: From baseline to week 16 post-dose
Change from baseline in Toronto Clinical Neuropathy Score (TCNS) at week 16
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.
Measured: From baseline to week 16 post-dose
Change from baseline in Nerve Conduction Velocities (NCVs) and Amplitude at week 16
To Compare SYHA1402 with placebo, the Nerve Conduction Velocities (NCVs) and Amplitude changes from baseline at week 16.
Measured: From baseline to week 16 post-dose
Change from baseline in Visual Analogue Scale (VAS) at week 16
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.
Measured: From baseline to week 16 post-dose
Change from baseline in the 36-Item Shot-Form Health Survey (SF-36) score at week 16
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).
Measured: From baseline to week 16 post-dose
Clearance (CL)
Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Clearance
Measured: Pre-dose and multiple timepoints up to 16 weeks
Volume of Distribution (V)
Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Volume of Distribution
Measured: Pre-dose and multiple timepoints up to 16 weeks
Pharmacodynamics (PD) indicator
Proportional change from baseline in whole blood/red blood cell sorbitol concentration (%)
Measured: Pre-dose and multiple timepoints up to 16 weeks
Incidence of adverse events (AEs)
Incidence of adverse events (AEs)
Measured: Throughout the study period, an average of 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start31 Dec 2021 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Symmetric Polyneuropathy (DSPN)Studies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116111
- Sponsor's protocol ID
- HA1403-CSP-004
- Status last verified
- Nov 2021
- First submitted
- 3 Sep 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Double-blind, Parallel-group, Placebo-controlled Phase II Study To Evaluate the Safety, Tolerance, Pharmacokinetics/Pharmacodynamics and Efficacy of SYHA1402 Tablets For the Treatment of Patients With Diabetic Peripheral Neuropathy in China
- ClinicalTrials.gov ID
- NCT05116111
- Acronym / sponsor ID
- HA1403-CSP-004
- Conditions
- Distal Symmetric Polyneuropathy (DSPN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 10 Nov 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SYHA1402 1000 mg plus placebo 500 mg | Experimental | Drug: SYHA1402 tablets, Drug: PlaceboEligible patients will be randomly assigned to receive SYHA1402 1000 mg and placebo 500 mg twice daily for 16 weeks of treatment after a placebo introduction period. |
| SYHA1402 1500 mg | Experimental | Drug: SYHA1402 tabletsEligible patients will be randomly assigned to receive SYHA1402 1500 mg twice daily for 16 weeks of treatment after a placebo introduction period. |
| Placebo 1500 mg | Placebo comparator | Drug: PlaceboEligible patients will be randomly assigned to receive placebo 1500 mg twice daily for 16 weeks of treatment after a placebo introduction period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Males or females, aged 18-75 years (both inclusive);
- 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;
- 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;
- Toronto Clinical Neuropathy Score (TCNS) ≥ 6 points, with sensory test score ≥ 2 points at screening and baseline.
Key exclusion criteria (28 listed)
- Patients with peripheral neuropathy caused by other diseases: such as cervical and lumbar vertebral disease, cerebrovascular disease, intracranial tumor or trauma, toxic peripheral neuropathy (e.g. chemotherapy, alcohol), Guillain-Barr é syndrome, multiple sclerosis, bone joints or tendon lesions, severe arteriovenous and vascular lesions, severe liver and kidney insufficiency, hyperthyroidism or degeneration, subclinical thyroid dysfunction, vitamin B12 deficiency, infection (e.g. human immunodeficiency virus), etc;
- Patients with previous peripheral arterial disease, and significant intermittent claudication symptoms or previous lower extremity vascular bypass or angioplasty at screening;
- History of malignant neoplasms (except cured basal cell skin cancer, in-situ carcinomas and papillary thyroid cancer) or history of antineoplastic therapy within 5 years prior to screening;
- Patients with a change of more than 2 points in the same item of the mTCNS at screening and baseline;
- Visual Analogue Scale (VAS) > 8 points at screening;
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 |
|---|---|---|
| SYHA1402 tabletsSYHA1402 tablets, oral, twice daily | Drug | SYHA1402 1000 mg plus placebo 500 mg, SYHA1402 1500 mg |
| PlaceboPlacebo, oral, twice daily | Drug | Placebo 1500 mg, SYHA1402 1000 mg plus placebo 500 mg |
Primary outcome
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS)- Sensory Test Score at week 16
Time frame: 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.
9 secondary outcomes
Change from baseline in overall score and symptom score of mTCNS at week 16
Time frame: From baseline to week 16 post-dose
Change from baseline in Toronto Clinical Neuropathy Score (TCNS) at week 16
Time frame: From baseline to week 16 post-dose
Change from baseline in Nerve Conduction Velocities (NCVs) and Amplitude at week 16
Time frame: From baseline to week 16 post-dose
Change from baseline in Visual Analogue Scale (VAS) at week 16
Time frame: From baseline to week 16 post-dose
Change from baseline in the 36-Item Shot-Form Health Survey (SF-36) score at week 16
Time frame: From baseline to week 16 post-dose
Clearance (CL)
Time frame: Pre-dose and multiple timepoints up to 16 weeks
Volume of Distribution (V)
Time frame: Pre-dose and multiple timepoints up to 16 weeks
Pharmacodynamics (PD) indicator
Time frame: Pre-dose and multiple timepoints up to 16 weeks
Incidence of adverse events (AEs)
Time frame: Throughout the study period, an average of 21 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYHA1402 tablets in people with Distal Symmetric Polyneuropathy (DSPN), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 5 inclusion and 28 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xinhua Xiao, Professor (+86-13911830085, xiaoxh2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS)- Sensory Test Score at week 16 (time frame: From baseline to week 16 post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2021.