NCT Number: NCT00180037
Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease
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.
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Notify MeKey information
Conditions
Age range
40 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Department of Neurology, University of Ulm, Ulm, Baden-Wurttemberg, Germany
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugPrimary outcomes
-
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Secondary outcomes
-
Total UPDRS
-
Safety
-
PDQ-39
-
SF36
-
CGI
-
Schwab&England
-
Montgomery-Asperg
-
Pain
-
Incontinence
-
Sexual behavior
Sponsors and collaborators
Lead sponsor
Technische Universität Dresden
Other
Collaborators
- Deutsche Parkinson-Vereinigung e.V.
- MSE Pharmazeutika GmbH, Bad Homburg
Registry information
Official study title
Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease
Important dates
- Study start
- 2003
- Primary completion
- 2005
- Study completion
- 2005
- First posted
- Sep 16, 2005
- Registry last updated
- Jan 19, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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