Back to resultsParkinson's Disease Treatment With Coenzyme Q10
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Coenzyme Q10
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, coenzyme Q10
Eligibility Criteria
Inclusion Criteria: The subjects must have the three cardinal features of PD: slowness of movement, resting tremor and rigidity. The signs of PD must be greater on one side. Exclusion Criteria: Disorders that mimic PD. Other serious medical problems.
Sites / Locations
- University of Rochester
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004731
First Posted
February 25, 2000
Last Updated
June 23, 2005
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00004731
Brief Title
Parkinson's Disease Treatment With Coenzyme Q10
Official Title
Effects of Coenzyme Q10 in Early Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
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 Parkinson's disease (PD) in patients with early, untreated PD.
Detailed Description
Four groups of 20 subjects/group of subjects will be randomly assigned to receive CoQ10 (at doses of 300, 600 or 1200 mg/day) 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 she/he 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, coenzyme Q10
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subjects must have the three cardinal features of PD: slowness of movement, resting tremor and rigidity. The signs of PD must be greater on one side.
Exclusion Criteria:
Disorders that mimic PD.
Other serious medical problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford W. Shults, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Parkinson's Disease Treatment With Coenzyme Q10
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