Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

Sponsor

Technische Universität Dresden (Other)

Overall Status

Completed

CT.gov ID

NCT00180037

Collaborator

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

132

Enrollment

Locations

Duration (Months)

10.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

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

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.

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, University of Ulm	Ulm	Baden-Württemberg	Germany	89081
2	Department of Neurology, Fachklinik Ichenhausen	Ichenhausen	Bavaria	Germany	89335
3	Department of Neurology, Leopoldina Krankenhaus	Schweinfurt	Bavaria	Germany	97422
4	Department of Neurology, University of Marburg	Marburg	Hessen	Germany	35039
5	Department of Neurology, Deutsche Klinik fuer Diagnostik	Wiesbaden	Hessen	Germany	65191
6	Department of Nuerology, Klinikum Lippe	Lemgo	Niedersachsen	Germany	32657
7	Department of Neurology, Klinikum Lueneburg	Lueneburg	Niedersachsen	Germany	21339
8	Department of Neurology, Ruhr-University of Bochum	Bochum	Nordrhein-Westfalen	Germany	44791
9	Department of Neurology, Klinikum Essen-Borbeck	Essen	Nordrhein-Westfalen	Germany	45359
10	Department of Neurology, Klinik Ambrock	Hagen	Nordrhein-Westfalen	Germany	58091
11	Department of Neurology, University of Homburg	Homburg	Saarland	Germany	66421
12	Department of Neurology, Technical University of Dresden	Dresden	Saxony	Germany	01307
13	Department of Neurology, Charite Berlin	Berlin		Germany	13353