Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

Study Overview
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Brief Summary
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This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage Parkinson's disease (PD) patients (Hoehn&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo. The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III. The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients.

Detailed Description
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This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage non-fluctuating Parkinson's disease (PD) patients (Hoehn&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo. The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes 100 mg Coenzyme Q10 nanodispersion (Nanoquinon solution) tid or matched placebo for three months. Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients. The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III. The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients. Main inclusion criteria: Parkinson's disease according to the UK Brain Bank criteria Hoehn & Yahr stadium II until III Age 40 to 75 years UPDRS Part III > 15 points No motor fluctuations or dyskinesias Stable medication for 4 weeks prior to inclusion Main exclusion criteria: Atypical parkinsonian syndromes Dyskinesias or motor fluctuations Coenzyme Q10 treatment in the past Pregnancy

Official Title
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Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Coenzyme Q10 Nanodispersion (Nanoquinone)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease according to the UK Brain Bank criteria Hoehn & Yahr stadium II until III Male or female Age 40 to 75 years UPDRS Part III > 15 points No motor fluctuations or dyskinesias Stable parkinsonian condition for 4 weeks prior to inclusion Outpatients Patients without or with stable levodopa treatment for 4 weeks prior inclusion Written informed consent Exclusion Criteria: Atypical or drug-induced parkinsonian syndromes Dyskinesias or motor fluctuations Coenzyme Q10 treatment in the past Pregnancy Epileptic seizures in the history Hypothyroidism Severe medical conditions with interference with study drug Treatment with CSE inhibitors, thyroidal hormones, antiarrhythmic drugs, warfarin, metformin Treatment or intake of vitamins, magnesium, vitamin E, calcium

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Coenzyme Q10 Nanodispersion (Nanoquinone)|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total UPDRS |  |  | 
| Safety |  |  | 
| PDQ-39 |  |  | 
| SF36 |  |  | 
| CGI |  |  | 
| Schwab&England |  |  | 
| Montgomery-Asperg |  |  | 
| Pain |  |  | 
| Incontinence |  |  | 
| Sexual behavior |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Coenzyme Q10, Treatment, Neuroprotection