Parkinson's Disease Treatment With Coenzyme Q10 - Full Text View

Sponsored by:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:	NCT00004731

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 II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Coenzyme Q10

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double-Blind, Parallel Assignment

Official Title:

Effects of Coenzyme Q10 in Early Parkinson's Disease

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

Genders Eligible for Study:

Both

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

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

Study ID Numbers:

R01NS36714

First Received:

February 25, 2000

Last Updated:

June 23, 2005

ClinicalTrials.gov Identifier:

NCT00004731

Health Authority:

United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):

Parkinson's disease
coenzyme Q10

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Ubiquinone
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Coenzyme Q10

Additional relevant MeSH terms:

Vitamins
Growth Substances
Physiological Effects of Drugs

Nervous System Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 06, 2009