JPRN-jRCTs061180060已完成2 期
Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease
agai Masahiro0 个研究点目标入组 26 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
Inosine was tolerable and it effectively increased the plasma level of urate but we did not observed a protective effect on the progression of Parkinson's disease
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Diagnosed as having Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria.
- •Confirmed negative for vascular Parkinsonism by Brain CT/MRI within one year
- •Within 5 years (60 months) from the start of any anti-Parkinsonism medication.
- •19 item-Wearing-off questionnaire <= 1 at the time of the screening visit and Visit 1.
- •Serum urate level <= 5.5 mg/dL in male or <= 4.2 mg/dL in female.
- •Age >=20 and obtained written informed consent.
排除标准
- •A history of kidney stones, gout(or chronic arthritis), ischemic heart disease
- •A history of kidney failure of eGFR <= 60 at the screening visit.
- •Having uncontrolled hypertension which is defined as SBP>=160 or DBP >=100
- •Current treatment with medication which slows urate excretion, which is defined as taking diuretics, losartan, anti-tuberculosis drugs or immune-suppression agents.
- •Being pregnant or having an intention to become pregnant during the study period.
- •Other factors that investigators deem inappropriate to enroll for the trial. (e.g. Having malignancy, arthritis which is difficult to discern from gout, severe allergic history to drugs)
研究者
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