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CompletedNCT00004731Updated Jun 24, 2005

Parkinson's Disease Treatment With Coenzyme Q10

A Phase 2 interventional study of Coenzyme Q10 in Parkinson's Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • Parkinson's disease
  • coenzyme Q10
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

Browse Parkinson Disease studies →

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 592 studies on the registry; 56 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Disorders that mimic PD.
  • Other serious medical problems.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • DrugCoenzyme Q10
06

Study locations

1 site
  • University of Rochester
    Rochester, New York 14620, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004731
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
First posted
Feb 28, 2000
Start date
Sep 1998
Completion
Oct 2003
Last update
Jun 24, 2005

Study contacts

Clifford W. Shults, M.D.
principal investigator · University of California, San Diego
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.

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