EUCTR2008-002843-18-BE进行中（未招募）1 期
A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center,Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects aged between 18 and 75 years old at screening
- •2. Subjects with type 1 or type 2, insulin-dependent or non insulin-dependent diabetes mellitus, with a diagnosis at least 12 months prior to screening
- •3. Subjects whose glycemic control has been optimized and stable for at least 3 months prior to screening.
- •Optimal glycemic control refers to the best possible diabetic control that an individual subject can attain with usual standards of care.
- •Stable control refers to no dose changes to existing medications for glycemic control (other than insulin) and no medications being initiated for glycemic control in the 3 months prior to screening
- •4. Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria:
- •Abnormal nerve conduction velocity of the sural nerve (= 1st percentile, corrected for age; table will provided by the Neurological Core Laboratory in the manual of electrophysiological testing procedures). If recordings are technically acceptable, absent sural nerve responses provide clear evidence of an abnormal” response.
- •Abnormal peroneal motor nerve conduction velocity (= 1st percentile, corrected for age; table will provided by the Neurological Core Laboratory in manual of electrophysiological testing procedures). Peroneal responses must be present, with an evoked compound muscle action potential in the extensor digitorum brevis muscle
- •=500 µV. Peroneal motor nerve conduction velocity must be greater than a value defined as 20% of the lower limit of normal (e.g. if the lower limit of normal is 40 m/sec, peroneal motor nerve conduction velocity must be = than 32 m/sec). Peroneal motor nerve conduction velocity will be recorded bilaterally on two separate occasions within 1-21 days of each other during the prerandomization period; both sets of recordings must fulfil the above criteria.
- •Decreased/absent ankle reflexes AND/OR decreased distal sensation in the lower limbs
- •Neuropathy Total Symptom Score-6 = 1 (at visit 1 and at visit 2)
- •5. Female subjects, who are of non-reproductive potential (=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal
- •cream). Male subjects with partners of child-bearing potential must also use adequate contraception
- •6. Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of diabetic foot ulcers (Wagner grade =1) or lower extremity amputation
- •2. Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms (e.g.sequelae of cerebrovascular disease, lumbar radiculopathy, entrapment neuropathy etc)
- •3. Subjects with a history of hypothyroidism or B12/folate deficiency or subjects with a low serum folate, vitamin B12 or elevated thyroid-stimulating hormone at screening, as defined by the central laboratory normal limits range
- •4. History or evidence of drug or alcohol abuse
- •5. History of known or suspected diagnosis of acquired immune deficiency syndrome, or who have tested seropositive for human immunodeficiency virus antibody or antigen previously
- •6. Significant cardiovascular disease such as:
- •Peripheral arterial occlusive disease (Fontaine Stage =IIa)
- •Clinically significant (in the opinion of the investigator) abnormal 12-lead electrocardiogram
- •New York Heart Association =class III heart failure
- •7. Significant hepatic disease, e.g.
- •Repeated alanine aminotransferase, aspartate transaminase, alkaline phosphatase > 2x the upper limit of normal at screening or total bilirubin >1.5x the upper limit of normal at screening
- •Positive result from hepatitis B or C screening tests or a history of a positive test at screening
- •8. History of hypoglycaemia resulting in loss of consciousness, diabetic ketoacidosis or hyperglycaemic hyperosmolar non-ketotic coma in the 3 months prior to screening
- •9. Morbid obesity (body mass index >40 kg/m2) at screening
- •10. Calculated creatinine clearance <50 mL/min at screening (see Appendix 2)
- •11. History of carcinoma within 5 years prior to screening, with the exception of basal cell carcinoma
- •12. Current major depressive disorder, bipolar disorder or a past history of suicide attempt or deliberate self-harm
- •13. Subjects who have received an investigational medicinal product within 3 months prior to the screening visit or subjects who have participated in a previous study with ranirestat
- •14. Clinically significant illness (e.g. unstable pulmonary, hematologic, renal, neurological or psychiatric disease etc) which, in the opinion of the investigator, would compromise a subject’s suitability to participate in the study for reasons of safety or would confound the efficacy assessments
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