Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180037
• Other study ID #: 78052003
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: January 16, 2009
• Start date: September 2003
• Est. completion date: June 2005

Study information

• Verified date: January 2009
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Coenzyme Q10 Nanodispersion (Nanoquinone)

• Placebo

Locations

Country	Name	City	State
Germany	Department of Neurology, Charite Berlin	Berlin
Germany	Department of Neurology, Ruhr-University of Bochum	Bochum	Nordrhein-Westfalen
Germany	Department of Neurology, Technical University of Dresden	Dresden	Saxony
Germany	Department of Neurology, Klinikum Essen-Borbeck	Essen	Nordrhein-Westfalen
Germany	Department of Neurology, Klinik Ambrock	Hagen	Nordrhein-Westfalen
Germany	Department of Neurology, University of Homburg	Homburg	Saarland
Germany	Department of Neurology, Fachklinik Ichenhausen	Ichenhausen	Bavaria
Germany	Department of Nuerology, Klinikum Lippe	Lemgo	Niedersachsen
Germany	Department of Neurology, Klinikum Lueneburg	Lueneburg	Niedersachsen
Germany	Department of Neurology, University of Marburg	Marburg	Hessen
Germany	Department of Neurology, Leopoldina Krankenhaus	Schweinfurt	Bavaria
Germany	Department of Neurology, University of Ulm	Ulm	Baden-Württemberg
Germany	Department of Neurology, Deutsche Klinik fuer Diagnostik	Wiesbaden	Hessen

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	Deutsche Parkinson-Vereinigung e.V., MSE Pharmazeutika GmbH, Bad Homburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Storch A, Jost WH, Vieregge P, Spiegel J, Greulich W, Durner J, Müller T, Kupsch A, Henningsen H, Oertel WH, Fuchs G, Kuhn W, Niklowitz P, Koch R, Herting B, Reichmann H; German Coenzyme Q(10) Study Group. Randomized, double-blind, placebo-controlled tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Secondary	Total UPDRS
Secondary	Safety
Secondary	PDQ-39
Secondary	SF36
Secondary	CGI
Secondary	Schwab&England
Secondary	Montgomery-Asperg
Secondary	Pain
Secondary	Incontinence
Secondary	Sexual behavior

External Links

•   Homepage of Principle study center