EUCTR2014-002295-87-IT进行中（未招募）1 期
A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •1. PD diagnosis consistent with UK Brain Bank Criteria
- •2. Good response to levodopa with at least 2 hours of wearing off
- •episodes in judgment of investigator
- •3. Stable doses of levodopa plus/minus other dopaminergic therapy
- •(minimum of 4 weeks for each drug)
- •4. MMSE score > 26
- •5. Capable of providing informed consent
- •6. No clinically significant medical, psychiatric or laboratory
- •abnormalities in the judgment of the investigator.
- •7. No history of psychosis or hallucinations in the past 6 months
- •8. Women who are capable of child bearing must have a negative urine
- •pregnancy test at screening visit and use an adequate contraceptive
- •method throughout the study.
- •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 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Atypical or secondary parkinsonism
- •2. Severe dyskinesia that might interfere with study performance in
- •judgment of investigator
- •3. Patient receiving duodopa, apomorphine infusion or DBS
- •4. Dysphagia or sialorrhea that might interfere with administration of
- •study intervention
- •5. Any relevant medical, surgical, or psychiatric condition, laboratory
- •value, or concomitant medication which, in the opinion of the
- •Investigator, would interfere with performing a pharmacokinetic study
- •or would interfere with drug absorption.
研究者
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