Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

January 16, 2009 updated by: Technische Universität Dresden

Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Department of Neurology, Charite Berlin
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Department of Neurology, University of Ulm
    • Bavaria
      • Ichenhausen, Bavaria, Germany, 89335
        • Department of Neurology, Fachklinik Ichenhausen
      • Schweinfurt, Bavaria, Germany, 97422
        • Department of Neurology, Leopoldina Krankenhaus
    • Hessen
      • Marburg, Hessen, Germany, 35039
        • Department of Neurology, University of Marburg
      • Wiesbaden, Hessen, Germany, 65191
        • Department of Neurology, Deutsche Klinik fuer Diagnostik
    • Niedersachsen
      • Lemgo, Niedersachsen, Germany, 32657
        • Department of Nuerology, Klinikum Lippe
      • Lueneburg, Niedersachsen, Germany, 21339
        • Department of Neurology, Klinikum Lueneburg
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • Department of Neurology, Ruhr-University of Bochum
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • Department of Neurology, Klinikum Essen-Borbeck
      • Hagen, Nordrhein-Westfalen, Germany, 58091
        • Department of Neurology, Klinik Ambrock
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Department of Neurology, University of Homburg
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Department of Neurology, Technical University of Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III

Secondary Outcome Measures

Outcome Measure
Safety
Pain
CGI
Total UPDRS
PDQ-39
SF36
Schwab&England
Montgomery-Asperg
Incontinence
Sexual behavior

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

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

Investigators

  • Principal Investigator: Heinz Reichmann, MD, Technical University of Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 19, 2009

Last Update Submitted That Met QC Criteria

January 16, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78052003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe