Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180037
Status:
COMPLETED
Last Update Posted:
2009-01-19
First Post:
2005-09-09
Brief Title:
Coenzyme Q10 as a Symptomatic Treatment in Parkinsons Disease
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Multicenter Placebo Controlled Randomized Double-Blinded Study Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage Parkinsons disease PD patients HoehnYahr 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 Parkinsons 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
The primary outcome measure was the combined Unified Parkinsons 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 Parkinsons disease PD patients HoehnYahr 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 Parkinsons 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
Parkinsons 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
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 Parkinsons 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
Parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None