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Parkinson's Disease Treatment With Coenzyme Q10

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ClinicalTrials.gov Identifier: NCT00004731
Recruitment Status : Completed
First Posted : February 28, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Coenzyme Q10 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Coenzyme Q10 in Early Parkinson's Disease
Study Start Date : September 1998
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004731


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14620
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Clifford W. Shults, M.D. University of California, San Diego
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00004731     History of Changes
Other Study ID Numbers: R01NS036714 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Parkinson's disease
coenzyme Q10

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Neurodegenerative Diseases
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins