A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg, 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 420
- 主要终点
- Nerve Conduction Studies
研究概览
简要总结
The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy
详细描述
The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is male or female, 18-70 years of age
- •The patient has either type 1 or type 2 diabetes
- •The patient has mild to moderate diabetic neuropathy
- •The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests
排除标准
- •Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix
- •A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition
- •Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function
- •Women of childbearing potential who do not refrain from sexual activity or use adequate contraception
- •Pregnant or lactating women
- •An ALT or AST value >2X upper limit of normal (ULN)
- •Clinically significant cardiovascular disease within the last six (6) months
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
干预措施: MCC-257 (Drug)
3
干预措施: MCC-257 (Drug)
4
干预措施: MCC-257 (Drug)
结局指标
主要结局
Nerve Conduction Studies
时间窗: Day 1, Week 24
次要结局
- Nerve fiber density(Day 1, Week 24)
- QST(Day 1, Week 12, Week 24)
- Symptom(Day 1, Week 12, Week 24)
- Clinical Global Impression(Week 12, Week 24)