Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

NCT ID: NCT00180037

Last Updated: 2009-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2005-06-30

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

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Coenzyme Q10 Nanodispersion (Nanoquinone)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsche Parkinson-Vereinigung e.V.

UNKNOWN

Sponsor Role: collaborator

MSE Pharmazeutika GmbH, Bad Homburg

UNKNOWN

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Principal Investigators

Heinz Reichmann, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Dresden

Locations

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, Germany

Department of Neurology, Fachklinik Ichenhausen

Ichenhausen, Bavaria, Germany

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

Department of Neurology, University of Homburg

Homburg, Saarland, Germany

Department of Neurology, Technical University of Dresden

Dresden, Saxony, Germany

Department of Neurology, Charite Berlin

Berlin, State of Berlin, Germany

Countries

Germany

References

Storch A, Jost WH, Vieregge P, Spiegel J, Greulich W, Durner J, Muller 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 trial on symptomatic effects of coenzyme Q(10) in Parkinson disease. Arch Neurol. 2007 Jul;64(7):938-44. doi: 10.1001/archneur.64.7.nct60005. Epub 2007 May 14.

Reference Type: RESULT

PMID: 17502459 (View on PubMed)

Related Links

http://www.neuro.med.tu-dresden.de

Homepage of Principle study center

Other Identifiers

78052003

Identifier Type: -

Identifier Source: org_study_id