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Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Coenzyme Q10 Nanodispersion (Nanoquinone)
Placebo
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Coenzyme Q10, Treatment, Neuroprotection

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, University of Ulm
  • Department of Neurology, Fachklinik Ichenhausen
  • Department of Neurology, Leopoldina Krankenhaus
  • Department of Neurology, University of Marburg
  • Department of Neurology, Deutsche Klinik fuer Diagnostik
  • Department of Nuerology, Klinikum Lippe
  • Department of Neurology, Klinikum Lueneburg
  • Department of Neurology, Ruhr-University of Bochum
  • Department of Neurology, Klinikum Essen-Borbeck
  • Department of Neurology, Klinik Ambrock
  • Department of Neurology, University of Homburg
  • Department of Neurology, Technical University of Dresden
  • Department of Neurology, Charite Berlin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2005
Last Updated
January 16, 2009
Sponsor
Technische Universität Dresden
Collaborators
Deutsche Parkinson-Vereinigung e.V., MSE Pharmazeutika GmbH, Bad Homburg
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1. Study Identification

Unique Protocol Identification Number
NCT00180037
Brief Title
Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease
Official Title
Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden
Collaborators
Deutsche Parkinson-Vereinigung e.V., MSE Pharmazeutika GmbH, Bad Homburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Coenzyme Q10, Treatment, Neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
132 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10 Nanodispersion (Nanoquinone)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Secondary Outcome Measure Information:
Title
Total UPDRS
Title
Safety
Title
PDQ-39
Title
SF36
Title
CGI
Title
Schwab&England
Title
Montgomery-Asperg
Title
Pain
Title
Incontinence
Title
Sexual behavior

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Reichmann, MD
Organizational Affiliation
Technical University of Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University of Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Department of Neurology, Fachklinik Ichenhausen
City
Ichenhausen
State/Province
Bavaria
ZIP/Postal Code
89335
Country
Germany
Facility Name
Department of Neurology, Leopoldina Krankenhaus
City
Schweinfurt
State/Province
Bavaria
ZIP/Postal Code
97422
Country
Germany
Facility Name
Department of Neurology, University of Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35039
Country
Germany
Facility Name
Department of Neurology, Deutsche Klinik fuer Diagnostik
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65191
Country
Germany
Facility Name
Department of Nuerology, Klinikum Lippe
City
Lemgo
State/Province
Niedersachsen
ZIP/Postal Code
32657
Country
Germany
Facility Name
Department of Neurology, Klinikum Lueneburg
City
Lueneburg
State/Province
Niedersachsen
ZIP/Postal Code
21339
Country
Germany
Facility Name
Department of Neurology, Ruhr-University of Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
Department of Neurology, Klinikum Essen-Borbeck
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45359
Country
Germany
Facility Name
Department of Neurology, Klinik Ambrock
City
Hagen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58091
Country
Germany
Facility Name
Department of Neurology, University of Homburg
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Department of Neurology, Technical University of Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
Department of Neurology, Charite Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17502459
Citation
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.
Results Reference
result
Links:
URL
http://www.neuro.med.tu-dresden.de
Description
Homepage of Principle study center

Learn more about this trial

Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

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