Parkinson's Disease Treatment With Coenzyme Q10

This study has been completed.

Sponsor:

Information provided by:

National Institute of Neurological Disorders and Stroke (NINDS)

ClinicalTrials.gov Identifier:

NCT00004731

First received: February 25, 2000

Last updated: June 23, 2005

Last verified: December 2003

History of Changes

Purpose

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
Parkinson's Disease	Drug: Coenzyme Q10	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effects of Coenzyme Q10 in Early Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Ubidecarenone

U.S. FDA Resources

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):


Study Start Date:	September 1998
Estimated Study Completion Date:	October 2003

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


ClinicalTrials.gov Identifier:	NCT00004731 History of Changes
Other Study ID Numbers:	R01NS036714 ( US NIH Grant/Contract Award Number )
Study First Received:	February 25, 2000
Last Updated:	June 23, 2005

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

ClinicalTrials.gov processed this record on June 23, 2017

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