A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 13
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline
研究概览
简要总结
In Parkinson's Disease, the mitochondrial membranes in cells that produce dopamine become damaged by oxidants, leading to the death of these cells and progressive tremor, slowness of movement and the loss of neurons in the substantia nigra (a part of the brain that is involved in movement). Mitoquinone is targeted to reach the membrane of mitochondria and provide protection from damaging oxidants. There are no treatments currently available to slow the progression of PD and this trial will help advance the development of this unique disease modifying drug.
This trial will enroll 120 participants with untreated early onset of PD. Participants will be randomized to receive 1 of 3 treatments: 40 mg of MitoQ tablets, 80 mg of MitoQ tablets or placebo. The researchers, participants and sponsor will all be blinded to the treatment allocation. Participants will be assessed after 1, 2, 3, 6, 9, 12 months of treatment and again 28 days after their last dose. The effectiveness of the trial drug will be measured via the Unified Parkinson's Disease Rating Scale (UPDRS). The safety of the trial drug will be monitored via regular participant examinations, blood tests, ECG and collecting information on adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •30 yrs or older
- •Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity)
- •Adequate contraceptive measures (females)
排除标准
- •Malignancy within last 2 years
- •Pregnancy & breast-feeding
- •Treatment with any anti-PD drugs within 30 days of enrolment
- •Prior treatment with anti-PD medication exceeding 42 days in total
- •Medication-induced PD/PD not of idiopathic origin
- •CoQ10/idebenone doses of 300mg/day or higher within 120 days, >25mg/day within 7 days of enrolment
- •Methylphenidate HCl, neuroleptics, reserpine, amphetamines, selegeline or MAOIs within 6 months of enrolment
- •CNS medications at unstable doses within 60 days of enrolment
- •Dietary supplements > 5 x RDI
- •Hypersensitivity to CoQ10, idebenone or any components of the study drug
- •Unable to swallow
- •Diseases with features of PD
- •Seizure(s) within 12 months prior to enrolment
- •UPDRS tremor score of 4
- •Hamilton Depression Rating Scale score > 10
- •History of stroke
- •Requirement for dopaminergic drugs
- •Modified Hoehn & Yahr score > 2.5
- •History of brain surgery for Parkinson's disease
- •History of structural brain disease / congenital brain abnormality
- •History of ECT
- •Any other clinically significant medical or psychiatric condition or lab abnormality
- •Enrolment in any other pharmacological study within 30 days of enrolment
研究组 & 干预措施
1
40 mg MitoQ OD
干预措施: MitoQ (Drug)
2
80 mg MitoQ OD
干预措施: MitoQ (Drug)
3
Placebo
干预措施: MitoQ (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline
时间窗: 12 months
次要结局
- The following assessments performed at the final study visit compared to baseline(12 months)
- UPDRS sub scores(12 months)
- Mini Mental State Examination(12 months)
- Schwab and England Scale(12 months)
- Modified Hoehn and Yahr Scale(12 months)
- Timed tapping score(12 months)
- The following safety outcomes will be measured over the course of the trial(12 months)
- Adverse events(12 months)
- ECG changes(12 months)
- Laboratory sample results(12 months)