Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborators:
Deutsche Parkinson-Vereinigung e.V.
MSE Pharmazeutika GmbH, Bad Homburg
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00180037
First received: September 9, 2005
Last updated: January 16, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Coenzyme Q10 Nanodispersion (Nanoquinone)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

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

Estimated Enrollment: 132
Study Start Date: September 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180037

Locations
Germany
Department of Neurology, University of Ulm
Ulm, Baden-Württemberg, Germany, 89081
Department of Neurology, Fachklinik Ichenhausen
Ichenhausen, Bavaria, Germany, 89335
Department of Neurology, Leopoldina Krankenhaus
Schweinfurt, Bavaria, Germany, 97422
Department of Neurology, University of Marburg
Marburg, Hessen, Germany, 35039
Department of Neurology, Deutsche Klinik fuer Diagnostik
Wiesbaden, Hessen, Germany, 65191
Department of Nuerology, Klinikum Lippe
Lemgo, Niedersachsen, Germany, 32657
Department of Neurology, Klinikum Lueneburg
Lueneburg, Niedersachsen, Germany, 21339
Department of Neurology, Ruhr-University of Bochum
Bochum, Nordrhein-Westfalen, Germany, 44791
Department of Neurology, Klinikum Essen-Borbeck
Essen, Nordrhein-Westfalen, Germany, 45359
Department of Neurology, Klinik Ambrock
Hagen, Nordrhein-Westfalen, Germany, 58091
Department of Neurology, University of Homburg
Homburg, Saarland, Germany, 66421
Department of Neurology, Technical University of Dresden
Dresden, Saxony, Germany, 01307
Department of Neurology, Charite Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Technische Universität Dresden
Deutsche Parkinson-Vereinigung e.V.
MSE Pharmazeutika GmbH, Bad Homburg
Investigators
Principal Investigator: Heinz Reichmann, MD Technical University of Dresden
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00180037     History of Changes
Other Study ID Numbers: 78052003
Study First Received: September 9, 2005
Last Updated: January 16, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Parkinson's disease
Coenzyme Q10
Treatment
Neuroprotection

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on August 27, 2014