Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 427
- 试验地点
- 1
- 主要终点
- Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)
研究概览
简要总结
Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.
BIA 9-1067 is currently being developed by BIAL (Portela & Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.
详细描述
This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD.
DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa
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 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and willing to sign an informed consent form.
- •Male and female subjects between 30 and 83 years old, inclusive.
- •Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.
- •Disease severity Stages I-III (modified Hoehn &Yahr staging) at ON.
- •Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement.
- •Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation.
- •On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening.
- •Signs of "wearing-off" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on the investigator's judgment.
排除标准
- •Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
- •Dyskinesia disability score >3 in the Unified Parkinson's Disease Rating Scale UPDRS) Sub-section IV A, item
- •Severe and/or unpredictable OFF periods.
- •Treatment with prohibited medication: entacapone, tolcapone, neuroleptics, venlafaxine, MAO inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening.
- •Treatment with apomorphine within the month before screening or likely to be needed at any time during the study.
- •Dosage change of concomitant anti-PD medication within 4 weeks of screening.
- •Previous or planned (during the entire study duration, including the OL period)deep brain stimulation.
- •Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.
- •Any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening.
- •Any medical condition that might place the subject at increased risk or interfere with assessments.
研究组 & 干预措施
Placebo
PLC, Placebo
干预措施: Placebo (Drug)
Placebo
PLC, Placebo
干预措施: Levodopa (Drug)
BIA 9-1067 25 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 25 mg once daily (QD).
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 25 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 25 mg once daily (QD).
干预措施: Levodopa (Drug)
BIA 9-1067 25 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 25 mg once daily (QD).
干预措施: Carbidopa (Drug)
BIA 9-1067 25 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 25 mg once daily (QD).
干预措施: Benserazide (Drug)
BIA 9-1067 50 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 50 mg once daily (QD).
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 50 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 50 mg once daily (QD).
干预措施: Levodopa (Drug)
BIA 9-1067 50 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 50 mg once daily (QD).
干预措施: Carbidopa (Drug)
BIA 9-1067 50 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 50 mg once daily (QD).
干预措施: Benserazide (Drug)
Placebo
PLC, Placebo
干预措施: Carbidopa (Drug)
Placebo
PLC, Placebo
干预措施: Benserazide (Drug)
结局指标
主要结局
Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)
时间窗: 14-15 weeks
Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.
次要结局
- UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)(14-15 weeks)
- Parkinson's Disease Sleep Scale (PDSS)(14-15 weeks)
- Non-motor Symptoms Scale (NMSS)(14-15 weeks)