NCT01950468撤回3 期
Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes
Navidea Biopharmaceuticals2 个研究点 分布在 1 个国家开始时间: 2017年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- The incidence of Parkinson' Syndrome based on the on-site neurologist assessment
研究概览
简要总结
This is a phase 3, open-label, multiple-center, randomized cross-over study to assess the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation
- •Age ≥ 40 years
- •Have had upper extremity tremor for < 3 years duration, regardless of presumed diagnosis or etiology
- •Have a UPDRS part III score upon entry of ≤ 16
排除标准
- •Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator
- •Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)
- •Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator
- •Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator
- •Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR [American Psychiatric Association, 1994])
- •Positive urine drug screen for opiates, cocaine, or amphetamines at screening
- •Positive pregnancy test before imaging
- •Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent
- •Previous scan with any DAT imaging agent (e.g. [123I]NAV5001, Altropane, DaTscan, DOPASCAN)
- •Any exposure to radiopharmaceuticals within 30 days before the date of informed consent
- •Breast-feeding
- •Inability to lie supine for 1 hour
- •Any thyroid disease other than adequately treated hypothyroidism
- •Known sensitivity or allergy to iodine or iodine containing products
- •Treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.
研究组 & 干预措施
NAV5001
Experimental
干预措施: NAV5001 (Drug)
DaTscan
Active Comparator
干预措施: DaTscan (Drug)
结局指标
主要结局
The incidence of Parkinson' Syndrome based on the on-site neurologist assessment
时间窗: Baseline
The incidence of Parkinson' Syndrome based on the Movement Disorder Specialist Consensus Panel
时间窗: One Year
The incidence of positve [123I]NAV5001 SPECT brain scans
时间窗: Baseline
次要结局
- Incidence of adverse events post baseline(1 year)
- The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 6 months(6 months)
- The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 1 year(1 Year)
研究者
研究点 (2)
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