Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations ("Wearing-off" Phenomenon)

Bial - Portela C S.A.7 个研究点分布在 2 个国家目标入组 40 人开始时间: 2010年2月最近更新: 2015年12月24日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 40
试验地点: 7
主要终点: Cmax - Observed Maximum Concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor.

详细描述

Multicentre, double-blind, randomised, placebo-controlled study in four parallel groups of PD patients treated with standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and with motor fluctuations ("wearing-off" phenomenon)

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: 30 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•At screening (admission to the baseline period):
•Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
•Age ≥ 30 years;
•A diagnosis of PD according to the UK PDS Brain Bank diagnostic criteria (bradykinesia and at least one of the following: muscular rigidity, rest tremor and postural instability);
•Predictable signs of end-of-dose deterioration despite "optimal" levodopa/carbidopa or levodopa/benserazide therapy;
•Modified Hoehn and Yahr stage of less than 5 in the "off" state; mean duration of "off" state ≥ 1.5 h during waking hours (based on historical information);
•Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of the patient or for the purpose of the study);
•Able and willing to give written informed consent.
•At randomisation (completion of the baseline period):
•Been treated with a stable regimen of 3 to 8 doses per day of standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) for at least 1 week prior to randomisation;
•Mean duration of "off" state ≥ 1.5 h during waking hours (average of recordings of last 3 evaluable days on patient's diary);
•Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses for at least 4 weeks prior to admission.

排除标准

•At screening (admission to the baseline period):
•Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
•Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors or imipramines [desipramine, imipramine, clomipramine and amitriptyline]), monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 2 weeks prior to admission;
•Treated with any investigational product within 1 month prior to admission (or within 5 half-lives, whichever is longer);
•A psychiatric or any medical condition that might place him/her at increased risk or interfere with assessments;
•Known hypersensitivity to any of the ingredients of the investigational products;
•A history of abuse of alcohol, drugs or medications within the last 2 years;
•A clinically relevant ECG abnormality;
•A history or current evidence of heart disease, including but not limited to myocardial infarction, angina, congestive heart failure and cardiac arrhythmia;
•Unstable concomitant disease being treated with changing doses of medication;
•A history or current evidence of any relevant disease in the context of this study, i.e., with respect to the safety of the patient (e.g., hepatic impairment) or related to the study conditions;
•A test positive for the HIV-1 or HIV-2 antibodies, or hepatitis B surface antigen (HbsAg), or hepatitis C antibody (HCVAb);
•Donated blood or received blood or blood products within the 6 months prior to admission;
•Pregnant, breast-feeding or of childbearing potential;
•Other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol.
•At randomisation (completion of the baseline period):
•Treated with levodopa/DDCI in a 10:1 ratio or in a controlled-release formulation during the baseline period;
•Treated with apomorphine during the baseline period;
•A clinically relevant ECG abnormality.