Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004731
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-25
Brief Title:
Parkinsons Disease Treatment With Coenzyme Q10
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
Effects of Coenzyme Q10 in Early Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2003-12
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:
The purpose of this study is to compare the effects of varying dosage of coenzyme Q10 CoQ10 versus a placebo in the treatment of Parkinsons disease PD in patients with early untreated PD
Detailed Description:
Four groups of 20 subjectsgroup of subjects will be randomly assigned to receive CoQ10 at doses of 300 600 or 1200 mgday or matching placebo A subject must have early PD that does not require treatment A subject will be evaluated at a Screening Visit a Baseline Visit after which the subject begins to take the study drug and visits at 1 4 8 12 and 16 months after the baseline visit The subject will be followed until shehe needs treatment with levodopa or for a maximum of 16 months Because CoQ10 is a component of the mitochondria the part of a cell that makes energy blood samples will be taken at the baseline visit and the last visit to study mitochondrial function
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: