Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])
研究概览
简要总结
The clinical syndrome of PSP responds poorly to all available forms of therapy used in Parkinson's Disease (PD). Currently, no effective treatment exists. Coenzyme Q10 in high doses has been shown to be a beneficial therapy in PD and might possibly be a beneficial therapy for PSP. This study will compare the efficacy, safety and tolerability of Coenzyme Q10 versus placebo in patients with atypical parkinsonian syndrome, progressive supranuclear palsy (PSP).
详细描述
The study is designed as a multicenter randomized, placebo-controlled, double blind trial. Up to 60 patients with PSP will be enrolled at several centers in the United States
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling the diagnostic criteria of PSP/diagnosed within the past 5 years
- •Either vertical supranuclear palsy or both slowing of vertical saccades
- •Prominent postural instability with falls in the first year of disease onset
- •No evidence of other diseases that could explain the foregoing features
排除标准
- •Current or previous therapeutic use of CoQ10
- •Parkinsonism due to drugs
- •History of pallidotomy, thalamotomy, active deep brain stimulator or fetal tissue transplant
- •History of active epilepsy, stroke, structural brain disease
- •Use of methylphenidate hydrochloride, cinnarizine, reserpine, amphetamines, or monoamine oxidase-A inhibitors within 3 months before the baseline visit.
- •Active cancer or cancer undergoing treatment
- •Participation in other drug studies or the use of other investigational drugs within 30 days before screening.
- •Known hypersensitivity to Coenzyme Q
- •Pregnant, planning a pregnancy or nursing woman
研究组 & 干预措施
CoQ10
Half of the enrolled patients will be randomized into the the CoQ10 arm and will receive a dosage of 2400mg/day of Coenzyme Q10
干预措施: Coenzyme Q10 (Dietary Supplement)
Placebo
Half of the enrolled patients will be randomized into the the Placebo arm and will receive a matching dose of placebo that resembles the 2400mg/day dose of the CoQ10 arm.
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])
时间窗: 12 months
Unified Parkinson's Disease Rating Scale \[UPDRS\]: Higher scores indicate a higher degree of impairment The total score is calculated by summing the subscores. Total scores range from 0 (normal) to 166 (severely impaired) Part I \[Mentation, Behavior, \& Mood\] Scale: 0-16 Part II \[Activities of Daily Living, Both "ON" \& "OFF"\] Scale:0-52 Part III \[Motor Examination\] Scale: 0-56 Part IV \[Complications of Therapy\] Scale: 0-34 Part V \[Modified Hoehn \& Yahr Staging\] Scale: 0-8 Part VI \[Schwab \& England Activities of Daily Living Scale\] Scale: 0 - 100% Progressive Supranuclear Palsy Rating Scale \[PSPRS\] - Total Scale ranges from 0 (normal) to 128 (severely impaired) Section 1 \[History\] Scale: 0-31 Section 2 \[Mentation\] Scale: 0-20 Section 3 \[Bulbar\] Scale: 0-10 Section 4 \[Ocular Motor\] Scale: 0-20 Section 5 \[Limb Motor\] Scale: 0-22 Section 6 \[Gait and midline\] Scale: 0-25
次要结局
- Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)(12 months)
- Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36](12 months)
- Safety Profile of Coenzyme Q10(12 months)
- Tolerability of Coenzyme Q10(12 months)