Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Coenzyme Q10, Treatment, Neuroprotection
Brief summary
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
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
Interventions
DRUGCoenzyme Q10 Nanodispersion (Nanoquinone)
DRUGPlacebo
Sponsors
Deutsche Parkinson-Vereinigung e.V.
MSE Pharmazeutika GmbH, Bad Homburg
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
| PDQ-39 | — |
| SF36 | — |
| CGI | — |
| Total UPDRS | — |
| Montgomery-Asperg | — |
| Pain | — |
| Incontinence | — |
| Sexual behavior | — |
| Schwab&England | — |
Countries
Germany
Outcome results
None listed