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临床试验/ACTRN12606000218594
ACTRN12606000218594进行中(未招募)2 期

A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients with Parkinson’s Disease

Antipodean Pharmaceuticals, Inc0 个研究点目标入组 120 人开始时间: 2006年5月31日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
120

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
30 Years 至 o limit(—)
性别
Female

入选标准

  • 1. Informed consent. 2. Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity). 3. Adequate contraceptive measures (females).

排除标准

  • 1. Malignancy within last 2 years2. Pregnancy & breast-feeding3. Treatment with any anti-PD drugs within 30 days of enrolment4. Prior treatment with anti-PD medication exceeding 42 days in total5. Medication-induced PD/PD not of idiopathic origin6. CoQ10/idebenone doses of 300mg/day or higher within 120 days, >25mg/day within 7 days of enrolment7. Methylphenidate HCl, neuroleptics, reserpine, amphetamines, selegeline or MAOIs within 6 months of enrolment8. CNS medications at unstable doses within 60 days of enrolment9. Dietary supplements > 5 x RDI10. Hypersensitivity to CoQ10, idebenone or any components of the study drug 11. Unable to swallow12. Diseases with features of PD 13. Seizure(s) within 12 months prior to enrolment14. UPDRS tremor score of 415. Hamilton Depression Rating Scale score > 1016. History of stroke17. Requirement for dopaminergic drugs18. Modified Hoehn & Yahr score > 2.519. History of brain surgery for Parkinson’s disease20. History of structural brain disease / congenital brain abnormality21. History of ECT22. Any other clinically significant medical or psychiatric condition or lab abnormality23. Enrolment in any other pharmacological study within 30 days of enrolment.

研究者

发起方
Antipodean Pharmaceuticals, Inc

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