A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 主要终点
- Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state
研究概览
简要总结
The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria
- •Meet Hoehn and Yahr PD stage
- •Good response to levodopa
- •Stable regimen of anti-parkinson medications
- •Are able to complete a Parkinson's disease diary
- •If of childbearing potential(male and female), use an acceptable method of birth control
- •Able and willing to sign an IRB/IEC approved informed consent
- •Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.
排除标准
- •Secondary or atypical Parkinson's
- •Neurosurgical intervention for Parkinson's disease
- •Treatment with apomorphine
- •Treatment with anti-psychotic drugs
- •Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation
- •MMSE less than 26
- •Subjects with untreated or uncontrolled current episode of major depression
- •Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses <100mg per day)
- •Women pregnant or lactating
- •History of hepatitis, cholangitis
- •Untreated or uncontrolled hypothyroidism or hyperthyroidism
- •Drops in blood pressure requiring medication to maintain blood pressure
- •Any clinically significant out of range laboratory evaluations
- •Known sensitivity to the study medication or its components
- •Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale
- •Finding of malignant melanoma on full body skin exam
- •Impulse disorder conditions
研究组 & 干预措施
Tozadenant (SYN115) 60 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
干预措施: Tozadenant (SYN115) 60 mg BID (Drug)
Tozadenant (SYN115) 60 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
干预措施: Levodopa (L-dopa) (Drug)
Tozadenant (SYN115) 120 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
干预措施: Levodopa (L-dopa) (Drug)
Tozadenant (SYN115) 120 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
干预措施: Tozadenant (SYN115) 120 mg BID (Drug)
Tozadenant (SYN115) 180 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
干预措施: Levodopa (L-dopa) (Drug)
Tozadenant (SYN115) 180 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
干预措施: Tozadenant (SYN115) 180 mg BID (Drug)
Tozadenant (SYN115) 240 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
干预措施: Levodopa (L-dopa) (Drug)
Tozadenant (SYN115) 240 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
干预措施: Tozadenant (SYN115) 240 mg BID (Drug)
Sugar Pill
White-coated, modified-oval placebo tablets.
干预措施: Placebo (Drug)
Sugar Pill
White-coated, modified-oval placebo tablets.
干预措施: Levodopa (L-dopa) (Drug)
结局指标
主要结局
Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state
时间窗: 12 weeks
次要结局
- To assess the effect of SYN115 on dyskinesia(12 weeks)
- To assess the effect of SYN115 on UPDRS scores(12 weeks)
- To assess investigator and patient impressions of PD severity and change(12 weeks)
- To assess the effect of SYN115 on non motor symptoms of PD(12 weeks)
- To assess the safety and tolerability of SYN115(12 weeks)
- To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation(12 weeks)