Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

Phase 3

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00180037
• Lead Sponsor: 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

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-16
• Last Update Posted: 2009-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III

Secondary Outcome Measures

Name	Time	Method
Total UPDRS
Safety
PDQ-39
SF36
CGI
Schwab&England
Montgomery-Asperg
Pain
Incontinence
Sexual behavior

Trial Locations

Locations (13)

Department of Neurology, Deutsche Klinik fuer Diagnostik; 🇩🇪 Wiesbaden, Hessen, Germany

Department of Nuerology, Klinikum Lippe; 🇩🇪 Lemgo, Niedersachsen, Germany

Department of Neurology, Fachklinik Ichenhausen; 🇩🇪 Ichenhausen, Bavaria, Germany

Department of Neurology, Klinikum Essen-Borbeck; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Department of Neurology, Klinik Ambrock; 🇩🇪 Hagen, Nordrhein-Westfalen, Germany

Department of Neurology, Technical University of Dresden; 🇩🇪 Dresden, Saxony, Germany

Department of Neurology, Charite Berlin; 🇩🇪 Berlin, Germany

Department of Neurology, University of Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

Department of Neurology, University of Homburg; 🇩🇪 Homburg, Saarland, Germany

Department of Neurology, Leopoldina Krankenhaus; 🇩🇪 Schweinfurt, Bavaria, Germany

Department of Neurology, Klinikum Lueneburg; 🇩🇪 Lueneburg, Niedersachsen, Germany

Department of Neurology, University of Marburg; 🇩🇪 Marburg, Hessen, Germany

Department of Neurology, Ruhr-University of Bochum; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany