EUCTR2014-005630-60-ES进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD
Biotie Therapies Inc.0 个研究点目标入组 449 人开始时间: 2015年10月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 449
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 158
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 292
排除标准
- •? Previous tozadenant study participation
- •? Current or recent participation in another study.
- •? Secondary or atypical parkinsonism
- •? Neurosurgical intervention for PD
- •? 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
研究者
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