Parkinson's Disease Treatment With Coenzyme Q10 - Tabular View

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Parkinson's Disease Treatment With Coenzyme Q10

This study has been completed.
Information provided by National Institute of Neurological Disorders and Stroke (NINDS)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Parkinson's Disease Treatment With Coenzyme Q10

Official Title ^†

Effects of Coenzyme Q10 in Early Parkinson's Disease

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Parallel Assignment

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Parkinson's Disease

Intervention ^†

Drug: Coenzyme Q10

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 1998

Completion Date

October 2003

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.

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00004731

Organization ID

R01NS36714

Secondary IDs ^††

Study Sponsor ^†

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators ^††

Investigators ^†

Principal Investigator:

Clifford W. Shults, M.D.

University of California, San Diego

Information Provided By

National Institute of Neurological Disorders and Stroke (NINDS)

Verification Date

December 2003

First Received Date ^†

February 25, 2000

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.