A Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 Sublingual Drops for Treating Diabetic Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percentage of patients with >30% reduction in neuropathic pain
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy
详细描述
A Phase 2a, two-center, randomized, double-blind, placebo-controlled study in which subjects will be randomized to receive either BOL-DP-o-04 or placebo in addition to Standart of Care. The study evaluates the effect of BOL-DP-o-04 for Diabetic Neuropathy. The study includes a screening period up to three weeks followed by a 12-week treatment period
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)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with Type 1 or Type 2 diabetes
- •Diabetes duration of at least 1 year
- •HbA1c 6%-12%
- •18 years of age or older
- •Diabetic neuropathy for at least 6 months
- •Failed or uncontrolled treatment of diabetic neuropathy following treatment with at least two drugs from the following drug list (Pregabalin / Dulexatine/ Amitriptyline / gabapentin /carbamazepine) for a duration of at least three months for each drug
- •Score equal or above 50% in DN4 questionnaire
排除标准
- •Neuropathic pain other than diabetic
- •A score of less than 50% on DN4 questionnaire
- •History of substance abuse (alcohol / illegal drugs)
- •History of cannabis or cannabis product usage in the last three months
- •Any decompensated chronic disease
- •Pregnancy/lactation
- •Participant in other clinical trial during the last 30 days
- •A current of history of cancer during the last year
- •Any mental/psychiatric illness in first-degree relative in a young patient <30 years old.
- •Any food allergy
- •History of amputation
- •Any disorder which in the investigator's opinion might jeopardize the subject's safety or compliance with the protocol
- •Patients with known allergy to one or more of the study drug components.
- •Patient with uncontrolled congestive heart failure
- •Subjects who get the following medications: opiates, Primidone, Phenobarbitol, carbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum
- •Patients with psychotic state in the past or anxiety disorder
- •Subject with a history of addiction or drug abuse.
研究组 & 干预措施
BOL-DP-o-04
干预措施: BOL-DP-o-04 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients with >30% reduction in neuropathic pain
时间窗: Baseline to week 15
Assessed by the DN4 questionnaire
Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: First treatment upto 15 weeks
All AEs will be recorded, whether considered minor or serious, drug-related or not
次要结局
- Improvement of QoL from baseline(Baseline to 15 weeks)
- Change from baseline of blood pressure(Baseline to 15 weeks)
- Change in weight(Baseline to 15 weeks)
- Change in HbA1c(Baseline to 15 weeks)
- Percentage of patients achieving HbA1c < 7%(Baseline to 15 weeks)
- Improvement in sleep disturbance(Baseline to 15 weeks)