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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00004731 |
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.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: Coenzyme Q10 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment |
Official Title: | Effects of Coenzyme Q10 in Early Parkinson's Disease |
Study Start Date: | September 1998 |
Estimated Study Completion Date: | October 2003 |
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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14620 |
Principal Investigator: | Clifford W. Shults, M.D. | University of California, San Diego |
Study ID Numbers: | R01NS36714 |
Study First Received: | February 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004731 |
Health Authority: | United States: Federal Government |
Parkinson's disease coenzyme Q10 |
Ganglion Cysts Movement Disorders Parkinson Disease Ubiquinone Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Coenzyme Q10 |
Vitamins Growth Substances Physiological Effects of Drugs |
Nervous System Diseases Micronutrients Pharmacologic Actions |