NCT00180037

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (planned)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Coenzyme Q10 Nanodispersion (Nanoquinone)
DRUG	Placebo

Timeline

• Start date: 2003-09-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2005-09-16
• Last updated: 2009-01-19

Locations

13 sites across 1 country: Germany