Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 132
- Locations
- 26
- Primary Endpoint
- Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Secondary Outcomes
- Total UPDRS
- Safety
- PDQ-39
- SF36
- CGI
- Schwab&England
- Montgomery-Asperg
- Pain
- Incontinence
- Sexual behavior