Effects of Coenzyme Q10 (CoQ) in Parkinson Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

The purpose of this study is to evaluate the safety and effectiveness of high dosages of Coenzyme Q10 in slowing clinical decline in people who have early Parkinson disease.

Key facts

Study ID

NCT00740714

Run by

Weill Medical College of Cornell University

People needed

600

Starts

2008-12-01

Expected to finish

2011-08-01

Last updated by the study team

2013-01-31

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of all 3 of the cardinal features of Parkinson disease (resting tremor, bradykinesia and rigidity). The clinical signs must be asymmetric.
• The diagnosis of Parkinson disease within 5 years prior to the Screening Visit.
• Age 30 or older.
• Female subjects must not be of childbearing potential or must use an approved form of contraception for the duration of the trial.

You may not qualify if…

• Use of any Parkinson disease medication within 60 days prior to the Baseline Visit.
• Duration of previous use of symptomatic medication for Parkinson disease cannot exceed 90 days such as levodopa, dopaminergic agonists (including ropinirole, pramipexole, pergolide, cabergoline, and the rotigotine transdermal system), selegiline, rasagiline, amantadine, and anticholinergic agents.
• Parkinsonism due to drugs including neuroleptics, alphamethyldopa, reserpine, metoclopramide, valproic acid.
• Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin.
• Other parkinsonian disorders.
• Modified Hoehn and Yahr score of 3 or greater at Screening Visit or Baseline Visit.
• UPDRS tremor score of 3 or greater at Screening Visit or Baseline Visit.
• Mini-Mental State Examination (MMSE) score of 25 or less.
• History of stroke.
• Disability sufficient to require treatment with dopaminergic medication or anticipated need for dopaminergic medication within next 3 months.
• Other serious illness, including psychiatric illness.
• Patients with active cardiovascular, peripheral vascular or cerebrovascular disease within the past year.
• Clinically serious abnormalities in the Screening Visit laboratory studies or electrocardiogram.
• Use of methylphenidate, cinnarizine, reserpine, amphetamine or a MAO-A inhibitor within 6 months prior to the Baseline Visit.
• Unstable dose of CNS active therapies.
• Use of appetite suppressants within 60 days prior to the Baseline Visit.
• History of active epilepsy within the last 5 years.
• Revised Hamilton Rating Scale for Depression of 11 or greater.
• Participation in other drug studies or use of other investigational drugs within 30 days prior to Screening Visit.
• History of electroconvulsive therapy.
• History of any brain surgery for Parkinson disease.
• History of structural brain disease such as prior trauma causing damage detected on a CT scan or MRI, hydrocephalus, or prior brain neoplasms.

Where it is running

• Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720 — Phoenix, Arizona, United States
• Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B — Scottsdale, Arizona, United States
• Sunhealth Research Institute, 10515 West Santa Fe Drive — Sun City, Arizona, United States
• The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204 — Fountain Valley, California, United States
• University of California Irvine, 100 Irvine Hall — Irvine, California, United States
• University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive — La Jolla, California, United States
• UCLA Medical Center, 710 Westwood Plaza, A-253 — Los Angeles, California, United States
• UC Davis Dept of Neurology, 4860 Y Street, Suite 3700 — Sacramento, California, United States
• The Parkinson's Institute, 675 ALMANOR AVENUE — Sunnyvale, California, United States
• Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511 — Aurora, Colorado, United States
• Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510 — Littleton, Colorado, United States
• The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B — New Haven, Connecticut, United States
• University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100 — Gainsville, Florida, United States
• University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5 — Miami, Florida, United States
• University of South Florida, 4 Columbia Drive, Suite 410 — Tampa, Florida, United States
• Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328 — Atlanta, Georgia, United States
• Movement Disorders Program, Department of Neurology, Medical College of Georgia — Augusta, Georgia, United States
• Northwestern University, 710 North Lake Shore Drive — Chicago, Illinois, United States
• Rush University Medical Center Department of Neurological Sciences, 1725 West Harrison Suite 755 — Chicago, Illinois, United States
• University of Chicago, 5841 South Maryland Avenue, Mc2030 — Chicago, Illinois, United States
• Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150 — Indianapolis, Indiana, United States
• University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive — Iowa City, Iowa, United States
• The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard — Kansas City, Kansas, United States
• University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606 — Louisville, Kentucky, United States
• University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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