A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off"
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 33
- 主要终点
- To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
研究概览
简要总结
Phase 3, international, multicenter, open-label 12 month safety study.
详细描述
Each patient will participate for up to 52 weeks, which includes a Screening Period, followed by a Baseline Visit and open-label treatment for 1 year with a safety Follow-up 4 weeks after the last treatment.
- Screening Period: up to 6 weeks.
- Open-Label Treatment Period: 52 weeks (1 year)
- Post-Treatment Safety Follow Up: 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form.
- •Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain Bank Diagnostic criteria
- •Minimum of 3 years since diagnosis.
- •Meet Hoehn and Yahr PD stage
- •Good response to levodopa
- •Stable regimen of anti-PD medications
- •Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months
- •Patient has documented a minimum amount of Off time.
- •If of childbearing potential (male and female) must use an acceptable method of contraception
排除标准
- •Previous tozadenant study participation
- •Current or recent participation in another study.
- •Secondary or atypical parkinsonism
- •Neurosurgical intervention for PD (except DBS if electrode placement has been performed over 12 months prior to screening)
- •Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®
- •Treatment with excluded medications
- •Untreated or uncontrolled hyperthyroidism or hypothyroidism
- •Clinically significant out-of-range laboratory
- •MMSE out of range
- •Current episode of major depression (stable treatment for depression is permitted).
- •Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Women lactating or pregnant
- •Hypersensitivity to any components of tozadenant or excipients
- •Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study
- •History of hepatitis or cholangitis
研究组 & 干预措施
Tozadenant
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
干预措施: Tozadenant (Drug)
结局指标
主要结局
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
时间窗: Up to 28 Weeks including safety follow-up visit.
The primary objective of this study was to evaluate the safety and tolerability of tozadenant in levodopa-treated Parkinson's Disease (PD) patients experiencing motor fluctuations, based on assessment of treatment-emergent adverse events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory tests. A total of 66 patients were enrolled in 27 study centers across 6 countries: USA, United Kingdom, Italy, Canada, Spain and Hungary, and were included in the Safety Set (SS).
次要结局
- To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)(Up to 28 Weeks including safety follow-up visit.)
- To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.(Up to 28 Weeks including safety follow-up visit.)
- To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.(Up to 28 Weeks including safety follow-up visit.)