A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Treatment-emergent Adverse Events
研究概览
简要总结
This study is a placebo-controlled, double-blind trial that will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. The medication will be administered orally as 8 ounces of hydrogen-enriched drinking water twice a day over the course of one year.
详细描述
This study will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. Subjects will be sequentially randomized in a 1:1 ratio to receive hydrogen-enriched water or the corresponding placebo twice a day, in addition to all standard-of-care treatments. Enrollment goal is 70 subjects. Duration of therapy is 52 weeks.
The primary outcome measures are safety and tolerability of hydrogen-enriched water. Secondary outcome measures include: progression of motor symptoms, health-related quality of life, progression of cognitive decline, and progression of symptom burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease
- •Modified Hoehn & Yahr Stage < III
- •Diagnosis of Parkinson's Disease made within past 3 years•
- •Ability to complete questionnaires
- •Willingness to go off parkinsonian medication for 12 hours prior to baseline and 56-week assessments
排除标准
- •Other major diseases of the central nervous system
- •History of stroke
- •Use of antipsychotic neuroleptic medication within the last 6 months
- •Symptomatic (secondary) parkinsonism
- •Atypical parkinsonian variants
- •Unstable medical or psychiatric illness
- •Known kidney disease
- •History of stereotactic brain surgery
- •Significant cognitive impairment
- •Inability to safely tolerate 8 ounces of water twice daily associated with the study medication
- •Unable to avoid regular use of medications containing magnesium
- •Treatment with another investigational drug within the last 30 days that may interfere with the study medication
- •Pregnancy or nursing
研究组 & 干预措施
Hydrogen tablets
The ingredient in the tablet producing H2 is magnesium. Each tablet contains 80 mg magnesium, a safe level well below the recommended daily dietary allowance of 420 mg for men/ 320 mg for women. Dissolving one tablet in 250 mL of water will achieve a saturating H2 concentration of approximately 1.6 ppm. Twice a day subjects will dissolve a tablet into water and drink the effervescent water.
干预措施: Hydrogen (Drug)
Placebo tablets
effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Number of Treatment-emergent Adverse Events
时间窗: 56 weeks
Number of treatment-emergent adverse events \[safety and tolerability\] of H2-enriched water in patients with Parkinson's disease (PD).
次要结局
- Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(56 weeks)
- Score on the Montreal Cognitive Assessment (MoCA)(56 weeks)
- Score on the Combined Part I, Part II, Part III, and Part IV Subscales of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(56 weeks)
- Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(56 weeks)
研究者
Carine Maurer
Assistant Professor
Stony Brook University