Clinical trial NCT00180037: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Coenzyme Q10
Treatment
Neuroprotection
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Deutsche Parkinson-Vereinigung e.V.
name: MSE Pharmazeutika GmbH, Bad Homburg
First posted: 2005-09-16
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Secondary outcomes:
measure: Total UPDRS
measure: Safety
measure: PDQ-39
measure: SF36
measure: CGI
measure: Schwab&England
measure: Montgomery-Asperg
measure: Pain
measure: Incontinence
measure: Sexual behavior
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Neurology, University of Ulm
state: Baden-Württemberg
city: Ichenhausen
country: Germany
facility: Department of Neurology, Fachklinik Ichenhausen
state: Bavaria
city: Schweinfurt
country: Germany
facility: Department of Neurology, Leopoldina Krankenhaus
state: Bavaria
city: Marburg
country: Germany
facility: Department of Neurology, University of Marburg
state: Hessen
city: Wiesbaden
country: Germany
facility: Department of Neurology, Deutsche Klinik fuer Diagnostik
state: Hessen
city: Lemgo
country: Germany
facility: Department of Nuerology, Klinikum Lippe
state: Niedersachsen
city: Lueneburg
country: Germany
facility: Department of Neurology, Klinikum Lueneburg
state: Niedersachsen
city: Bochum
country: Germany
facility: Department of Neurology, Ruhr-University of Bochum
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Department of Neurology, Klinikum Essen-Borbeck
state: Nordrhein-Westfalen
city: Hagen
country: Germany
facility: Department of Neurology, Klinik Ambrock
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Department of Neurology, University of Homburg
state: Saarland
city: Dresden
country: Germany
facility: Department of Neurology, Technical University of Dresden
state: Saxony
city: Berlin
country: Germany
facility: Department of Neurology, Charite Berlin
Study officials:
affiliation: Technical University of Dresden
name: Heinz Reichmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.