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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

February 25, 2000
June 23, 2005
September 1998
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Complete list of historical versions of study NCT00004731 on ClinicalTrials.gov Archive Site
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Parkinson's Disease Treatment With Coenzyme Q10
Effects of Coenzyme Q10 in Early Parkinson's Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Parkinson's Disease
Drug: Coenzyme Q10
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2003
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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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004731
R01NS36714
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National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Clifford W. Shults, M.D. University of California, San Diego
National Institute of Neurological Disorders and Stroke (NINDS)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP