A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- This is an exploratory study to evaluate effects of SYN115 in patients with PD, as determined by clinical and fMRI evaluation. The results of this initial study will help determine the range to be used in subsequent studies.
研究概览
简要总结
This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered.
详细描述
This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive design will be used to determine if SYN115 elicits effects relevant to PD in the fewest number of patients by performing interim analyses in successive cohorts of patients receiving 60 or 20 mg.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease
- •Hoen and Yahr stage 1-3
- •On stable dose of anti-parkinsons treatment for 30 days prior to screening
- •Age 40 to 75 years
- •Sign an IRB approved informed consent
- •Men and women agree to use adequate birth control
- •ECG measurements are within normal limits
- •Able to understand study requirements
排除标准
- •Secondary Parkinson's (drug induced or post stroke)
- •Received treatment with other investigational drug 30 days prior to study entry
- •Using disallowed medications
- •Significant neurological illness other than Parkinson's
- •IQ less than 70 on IQ test
- •MMSE score < or = 23
- •History of psychosis or on anti-psychotic medication
- •Current serious medical illness
- •History of substance abuse
- •History of head injury with loss of consciousness
- •History of brain surgery
- •Contraindications to MRI like claustrophobia, metal implants or other implantable devices
- •Abnormal liver function tests and/or hepatitis or cholangitis
- •Gilberts disease
- •Pregnant or nursing
- •Known hypersensitivity to SYN115
研究组 & 干预措施
1
Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
干预措施: Tozadenant (Drug)
2
Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
This is an exploratory study to evaluate effects of SYN115 in patients with PD, as determined by clinical and fMRI evaluation. The results of this initial study will help determine the range to be used in subsequent studies.
时间窗: Before treatment and at the end of each treatment period
次要结局
- Pittsburgh side effect scale(Before, after the first dose and end of each treatment period)
- Measurement of motor symptoms of Parkinson's disease and tapping speed(Before, after the first dose and end of each treatment period)
- VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety(Before, after the first dose and end of each treatment period)