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

Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

Sponsors

Lead sponsor: Technische Universität Dresden

Collaborator: Deutsche Parkinson-Vereinigung e.V.
MSE Pharmazeutika GmbH, Bad Homburg

Source Technische Universität Dresden
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

Overall Status Completed
Start Date September 2003
Completion Date June 2005
Primary Completion Date June 2005
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Secondary Outcome
Measure Time Frame
Total UPDRS
Safety
PDQ-39
SF36
CGI
Schwab&England
Montgomery-Asperg
Pain
Incontinence
Sexual behavior
Enrollment 132
Condition
Intervention

Intervention type: Drug

Intervention name: Coenzyme Q10 Nanodispersion (Nanoquinone)

Intervention type: Drug

Intervention name: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum age: 40 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Heinz Reichmann, MD Principal Investigator Technical University of Dresden
Location
facility
Department of Neurology, University of Ulm | Ulm, Baden-Württemberg, 89081, Germany
Department of Neurology, Fachklinik Ichenhausen | Ichenhausen, Bavaria, 89335, Germany
Department of Neurology, Leopoldina Krankenhaus | Schweinfurt, Bavaria, 97422, Germany
Department of Neurology, University of Marburg | Marburg, Hessen, 35039, Germany
Department of Neurology, Deutsche Klinik fuer Diagnostik | Wiesbaden, Hessen, 65191, Germany
Department of Nuerology, Klinikum Lippe | Lemgo, Niedersachsen, 32657, Germany
Department of Neurology, Klinikum Lueneburg | Lueneburg, Niedersachsen, 21339, Germany
Department of Neurology, Ruhr-University of Bochum | Bochum, Nordrhein-Westfalen, 44791, Germany
Department of Neurology, Klinikum Essen-Borbeck | Essen, Nordrhein-Westfalen, 45359, Germany
Department of Neurology, Klinik Ambrock | Hagen, Nordrhein-Westfalen, 58091, Germany
Department of Neurology, University of Homburg | Homburg, Saarland, 66421, Germany
Department of Neurology, Technical University of Dresden | Dresden, Saxony, 01307, Germany
Department of Neurology, Charite Berlin | Berlin, 13353, Germany
Location Countries

Germany

Verification Date

January 2009

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov