Trial | NCT00180037  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ubiquinone ...

  • Study Participants

    132
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.
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 Started
Sep 30
2003
Primary Completion
Jun 30
2005
Study Completion
Jun 30
2005
Last Update
Jan 19
2009
Estimate

Drug Coenzyme Q10 Nanodispersion (Nanoquinone)

Drug Placebo

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
No Results Posted