Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of eltoprazine to treat levodopa-induced dyskinesia in patients with Parkinson's disease
详细描述
A double-blind, placebo-controlled, crossover, dose-range finding study in patients with Parkinson's disease and levodopa-induced dyskinesia. The study will examine the effects of three different doses of eltoprazine HCl, compared to placebo, on severity of dyskinesia, parkinsonian symptoms, patient function, safety and tolerability, using Parkinson's disease rating scales, patient diaries and physiological measurement of abnormal movement by means of motion sensors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatient with idiopathic PD
- •stable dose of anti-parkinsonian medication for at least four weeks before the Screening Visit
- •daily levodopa dose ≥300 mg per day divided into at least three doses
- •treated with levodopa for at least three years prior to study entry
- •moderate to severely disabling levodopa-induced dyskinesia for at least three months prior to study entry
- •dyskinesia for, on average, >25% of the waking day
排除标准
- •inability to use the motion sensors or electronic diaries correctly
- •surgical treatment for PD, e.g. Deep Brain Stimulation, within the last six months or planned during the study
- •unstable co-existing psychiatric disease including psychosis, depression or cognitive impairment
- •Mini Mental State Examination score of <24
- •moderate or severe renal, or severe hepatic, impairment
- •treatment with selective serotonin re-uptake inhibitors (SSRI) or any combined serotonin-norepinephrine re-uptake inhibitors (SNRI), such as tryptizol, citalopram, escitalopram, sertraline, mianserin, mirtazapin, paroxetin, venlafaxine and St John's Wort, within four weeks prior to the Screening Visit
- •treatment with medications with the potential for drug-interactions (MAO-A inhibitors, apomorphine, aripiprazol, carbamazepine, clozapine, phenytoin, tramadol, quetiapine, varfaine, valproic acid). Patients taking amantadine will comprise no more than 25% of the study population
- •current history of a clinically significant and uncontrolled medical condition that may affect the safety of the patient or preclude adequate participation in the study
- •pregnant or breast-feeding
- •received any other investigational medicinal product within 30 days of Screening
研究组 & 干预措施
Eltoprazine HCl 2.5 mg
Eltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) for 3 weeks
干预措施: Eltoprazine HCl (Drug)
Eltoprazine HCl 5.0 mg
Eltoprazine HCl 5.0 mg capsules to be taken orally b.i.d. (ie, 10 mg/day) for 3 weeks
干预措施: Eltoprazine HCl (Drug)
Eltoprazine HCl 7.5 mg
Eltoprazine HCl 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks
干预措施: Eltoprazine HCl (Drug)
Placebo
Placebo capsules to be taken orally b.i.d. for 3 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
时间窗: 84 days
Clinical impact on dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score at the end of each Treatment Period on Days 21, 42, 63 and 84
次要结局
- Dyskinesia severity using physiological motion sensor system(84 days)
- • PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system(84 days)
- Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.(84 days)
- Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG(94 days)