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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, Germany
Department of Neurology, Fachklinik Ichenhausen
Ichenhausen, Bavaria, Germany
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Total UPDRS
Safety
PDQ-39
SF36
CGI
Schwab&England
Montgomery-Asperg
Pain
Incontinence
Sexual behavior
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Enrollment
132
Department of Neurology, Leopoldina Krankenhaus
Schweinfurt, Bavaria, Germany
Department of Neurology, University of Marburg
Marburg, Hesse, Germany
Department of Neurology, Deutsche Klinik fuer Diagnostik
Wiesbaden, Hesse, Germany
Department of Nuerology, Klinikum Lippe
Lemgo, Lower Saxony, Germany
Department of Neurology, Klinikum Lueneburg
Lüneburg, Lower Saxony, Germany
Department of Neurology, Ruhr-University of Bochum
Bochum, North Rhine-Westphalia, Germany
Department of Neurology, Klinikum Essen-Borbeck
Essen, North Rhine-Westphalia, Germany
Department of Neurology, Klinik Ambrock
Hagen, North Rhine-Westphalia, Germany
...and 3 more locations