NCT03899324Unknown2 期
A Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's Disease
B&A Therapeutics1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study is the change from baseline (V2) to endpoint (V5) in the MDS-UPDRS III motor score, evaluated 1 hour after the intake of the study treatment (Bumetanide or placebo) in patients in the OFF state.
研究概览
简要总结
This is multicentre, proof of concept, randomized, double-blind, parallel-group, placebo-control study in 40 Parkinson's Disease (PD) patients. Patients will be randomized in 2 groups receiving Bumetanide or placebo for 4 months:
- Group 1 (20 PD patients): bumetanide
- Group 2 (20 PD patients): placebo intake identically to group 1.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease fulfilling the UK Parkinson's Disease Brain Bank (UKPDSBB) criteria (cf. Appendix VII)
- •40 < Age < 80 years old
- •Hoehn & Yahr 1.5-4 (OFF stage)
- •Walking and balance or freezing ≥ 1in the MDS-UPDRS II
- •Motor fluctuation defined by a score ≥ 1 on the item "time spent in the OFF state" of the MDS-UPDRS IV
- •Dose of L-DOPA ≥ 150 mg/d (concomitant treatment)
- •PD medications regimen stable for at least 3 months
- •Patients expected to remain on stable doses of PD medications during all the study
- •Covered by Health Insurance System
- •Able to understand and to sign the informed consent prior to selection
- •Negative pregnancy test at screening
- •Blood Pressure (BP) and Heart Rate (HR) considered Non Clinicaly Significant (NCS) by investigators
- •Electrocardiogram (ECG) recording on a 12-lead ECG considered NCS by investigators
- •Laboratory parameters within the normal range of the laboratory. Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator
排除标准
- •Atypical parkinsonism or drug-induced parkinsonism
- •Cognitive impairment (MMSE ≤ 24)
- •Active psychiatric disorder (mood disorders, hallucinations or delirium with strong functional impact and not controlled by medication or which happened during the last 3 months before inclusion)
- •Treatment by Deep Brain Stimulation or continuous infusion of apomorphin/dopa gel
- •Renal or hepatic insufficiency
- •Electrolyte disturbances
- •A corrected QT (QTcF) interval >450ms for male or >470ms for female on the electrocardiogram
- •Any medical condition that might interfere with the protocol except those defined in Section 5.3
- •Contraindications to bumetanide : persistent anuria, hepatic encephalopathy included coma
- •Women pregnant, nursing or of childbearing age without effective contraception. Patients should not be enrolled if they plan to become pregnant during the time of study participation
- •Patient unable to attend scheduled visits or to comply to the protocol
- •Patient under legal guardianship or judicial protection
- •Patient in the exclusion period of another protocol
- •No possibility of contact in case of emergency
- •Known allergic reactions induced by Burinex (Bumetanide)
研究组 & 干预措施
Group 1: Experimental Bumetanide
Experimental
bumetanide with a titration period
干预措施: Bumetanide white, oblong, scored tablet (Drug)
Group 2: Placebo comparator
Placebo Comparator
placebo intake identically to group 1
干预措施: Placebo white, oblong, scored tablet (Drug)
结局指标
主要结局
The primary endpoint of this study is the change from baseline (V2) to endpoint (V5) in the MDS-UPDRS III motor score, evaluated 1 hour after the intake of the study treatment (Bumetanide or placebo) in patients in the OFF state.
时间窗: Between Day 1 and Day 120
次要结局
- Stand-Walk-Sit test at D1 (V2), D30 (V3), D60 (V4) and D120 (V5).(Day 1, Day 30, Day 60, Day 120)
- Change from V2 to V5 of the MDS-UPDRS part III and part I measured in a patient in the ON state.(Between Day 1 and Day 120)
- Change of scores of the MDS-UPDRS part II, III and IV during the trial, at D1 (V2), D30 (V3), D60 (V4) and D120 (V5).(Day 1, Day 30, Day 60, Day 120)
- Number of adverse events collected at each visit and phone calls.(Throughout the completion of the study, from Day 1 to Day 135)
研究者
研究点 (1)
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