NCT04044547已完成1 期
A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- LY03003 concentration in plasma
研究概览
简要总结
This study is to characterize the pharmacokinetics and to evaluate the safety as well as tolerability of LY03003 following multiple escalating intramuscular injections
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient had Parkinson's Disease that meet the clinical diagnostic criteria of the brain bank of the Parkinson's Disease Association of the United Kingdom.
- •Patient was Hoehn & Yahr stage ≤3 (excluding stage 0) ;
- •Patient was male or female aged 18 to 75 years;
- •Patient had a Mini Mental State Examination (MMSE) score of ≥25;
- •Patient had a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of ≤30 at Screening.
- •Patient who signed the informed consent form volunteered to participate in this clinical trial and could cooperate with the prescribed inspections.
排除标准
- •Patient had a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant;
- •Patient had dementia, schizophrenia or hallucinations, or clinically significant depression;
- •Patient had a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or presence of suicidal tendency in the past year;
- •Patient had a history of orthostatic hypotension.
- •Patient had received therapy with a dopamine (DA) agonist either concurrently or had done so within 28 days prior to the Screening;
- •Patient had received therapy with 1 of the following drugs either concurrently or within 28 days prior to Screening: monoamine oxidase B (MAO-B) inhibitors (e.g., pargyline, selegiline), DA releasing agents (e.g., amphetamine), reserpine, DA-antagonists (e.g., metoclopramide), neuroleptics, or other medications that may interact with DA function;
- •Patient was currently (at the time of Screening) receiving central nervous system active therapy (e.g., sedatives, hypnotics, antidepressants, anxiolytics), unless the dose had been stable for at least 28 days prior to Screening Visit and was likely to remain stable for the duration of the study;
- •Patient had a current diagnosis of epilepsy, had a history of seizures as an adult within 1 year prior to Screening, had a history of stroke or transient ischemic attack within 3 months prior to Screening;
- •Patient had a history of known intolerance/hypersensitivity to non-dopaminergic antiemetics, such as domperidone, ondansetron, tropisetron;
- •Patient had any other clinically relevant hepatic, renal, and cardiac dysfunction, or laboratory abnormality, which would have, in the judgment of the Investigator, interfered with the patient's ability to participate in the study;
- •Patient had a history of allergic to any medication;
- •Heavy smoker, alcoholic, drug addict;
- •Female patients who were pregnant or were breastfeeding or were of childbearing potential without adequate contraception;
- •Patient who was inappropriate to participant in the study in the judgment of the Investigator.
研究组 & 干预措施
LY03003
Experimental
干预措施: Rotigotine, extended-release microspheres (Drug)
Placebo
Placebo Comparator
干预措施: Placebo, extended-release microspheres (Drug)
结局指标
主要结局
LY03003 concentration in plasma
时间窗: Days 1, 2, 4, 6, 8, 15, 22, 29, 30, 32, 34, 36, 38, 40, 43, and day 50
次要结局
- Frequency of adverse events(From screening up to day 50)
- Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅲ) Total Score(screening, baseline and day 29 and Day 50)
研究者
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