Effects of Coenzyme Q10 (CoQ) in Parkinson Disease
- Conditions
- Parkinson Disease
- Interventions
- Drug: Coenzyme Q10 with vitamin EDrug: placebo with vitamin E
- Registration Number
- NCT00740714
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
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.
- Detailed Description
Parkinson disease (PD) is a progressive neurodegenerative disease that affects more than 1,000,000 Americans. Currently there is no proven therapy to reduce the rate of progression of PD. In a previous phase II clinical trial, investigators demonstrated that Coenzyme Q10 (CoQ) at dosages of 300, 600, and 1200 mg/day was safe and well-tolerated in individuals with early, untreated PD. The findings also suggested that CoQ may slow the progressive impairment of PD as measured by the Unified Parkinson Disease Rating Scale (UPDRS).
In this study, researchers will conduct a randomized, placebo-controlled, phase III trial of CoQ to confirm and extend the results of the earlier phase II study. The primary objective of this trial is to compare the effect of two dosages of CoQ (1200 and 2400 mg/day) and placebo on the total UPDRS score in people with early PD. The study also will evaluate independent function, cognition, and quality of life. Plasma CoQ levels will be measured at months 1, 8 and 16 and correlated with changes in UPDRS scores.
Participants will be randomly assigned to receive a placebo (an inactive substance), 1200 mg/d CoQ, or 2400 mg/d CoQ. They will be evaluated at screening, baseline, and during visits at months 1, 4, 8, 12, and 16. Information gained from this trial could lead to changes in management of people with early PD.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Coenzyme Q10 with vitamin E Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day) B Coenzyme Q10 with vitamin E Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day) C placebo with vitamin E Placebo (with vitamin E 1200 IU/day)
- Primary Outcome Measures
Name Time Method Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176)) Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176.
- Secondary Outcome Measures
Name Time Method Change in Modified Schwab & England Independence Scale From Baseline to 16 Months Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden).
Change in Modified Rankin Scale From Baseline to 16 Months Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention.
Change in PD Quality of Life Scale From Baseline to 16 Months Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life.
Change in Symbol Digit Modalities Test From Baseline to 16 Months Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome).
Change in Hoehn & Yahr Score From Baseline to 16 Months Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided).
CoQ10 Levels in Plasma Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first Based on samples analyzed to date
Adverse Experiences: Back Pain Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with back pain
Adverse Experiences: Constipation Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with constipation
Adverse Experiences: Insomnia Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with insomnia
Adverse Experiences: Anxiety Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with anxiety
Adverse Experiences: Tremor Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with tremor
Adverse Experiences: Nasopharyngitis Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with nasopharyngitis
Adverse Experiences: Diarrhoea Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with diarrhoea
Adverse Experiences: Headache Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with headache
Adverse Experiences: Urinary Tract Infection Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of patients with urinary tract infections
Adverse Experiences: Nausea Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with nausea
Adverse Experiences: Hypertension Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with hypertension
Adverse Experiences: Depression Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with depression
Adverse Experiences: Constipation: Moderate/Severe Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with moderate/severe constipation
Adverse Experiences: Anxiety: Moderate/Severe Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with moderate/severe anxiety
Adverse Experiences: Back Pain: Moderate/Severe Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with moderate/severe back pain
Adverse Experiences: Insomnia: Moderate/Severe Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) Number of participants with moderate/severe insomnia
Trial Locations
- Locations (68)
University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive
🇺🇸Iowa City, Iowa, United States
Northshore-Lij Health System, the Feinstein Institute Fpr Medical Research, 350 Community Drive Room 100
🇺🇸Manhasset, New York, United States
Columbia University, 710 West 168Th Street, 3Rd Floor
🇺🇸New York, New York, United States
The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard
🇺🇸Kansas City, Kansas, United States
Parkinson'S Dis & Movement Disorders Inst, 428 East 72Nd Street, Suite 400
🇺🇸New York, New York, United States
Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Room 5Ho1
🇺🇸New York, New York, United States
Semmes Murphey Clinic, 1211 Union Avenue, Suite 200
🇺🇸Memphis, Tennessee, United States
CHUM-HOPITAL NOTRE DAME, 1560 rue SHERBROOKE est ROOM GR 1185, PAVILLON DECHAMPS etage rez-de-chaussee
🇨🇦Montreal, Quebec, Canada
Weill Medical College of Cornell
🇺🇸New York, New York, United States
Washington University School of Medicine, 660 South Euclid, Box 8111
🇺🇸St Louis, Missouri, United States
Neurohealth Parkinson'S Disease, Movement Disorder Center, 227 Centerville Road
🇺🇸Warwick, Rhode Island, United States
Toronto Western Hospital, Univ Health Network, 399 Bathurst Street Mc 7-402, Movement Disorders Centre
🇨🇦Toronto, Ontario, Canada
Quebec Memory and Motor Skills Dis Clinic, Price Building 3Rd Floor, 65 Sainte-Anne Street
🇨🇦Quebec, Canada
Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
🇺🇸Atlanta, Georgia, United States
University of Pennsylvania, Pennsylvania Hospital Department of Neurology, 330 South 9Th Street
🇺🇸Philadelphia, Pennsylvania, 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
The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31
🇺🇸Cleveland, Ohio, United States
Parkinson & Movement Dis Center If Maryland, 8180 Lark Brown Road, Suite 101
🇺🇸Elkridge, Maryland, United States
University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5
🇺🇸Miami, Florida, United States
Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 809D
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine - Parkinson'S, Disease Center and Movement Disorders Clinic, 65501 Fannin St, Suite 1801
🇺🇸Houston, Texas, United States
University of Minnesota, 420 Delaware Street SE, Mmc 295
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213
🇺🇸Durham, North Carolina, United States
Royal University Hospital, 103 Hospital Drive, Room 1663
🇨🇦Saskatoon, Saskatchewan, Canada
University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
🇺🇸Birmingham, Alabama, United States
Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720
🇺🇸Phoenix, Arizona, United States
University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100
🇺🇸Gainsville, Florida, United States
Oregon Health & Science University, Dept of Neurology, 3181 SW Sam Jackson Park Road Op-32
🇺🇸Portland, Oregon, United States
University of Sherbrooke, 3001 12E Avenue Nord
🇨🇦Sherbrooke, Quebec, Canada
Medical College of Wisconsin, Department of Neurology, 9200 West Wisconsin Avenue
🇺🇸Milwaukee, Wisconsin, United States
University of Rochester Department of Neurology, 919 Westfall Road Building C Suite 220
🇺🇸Rochester, New York, United States
Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511
🇺🇸Aurora, Colorado, United States
UC Davis Dept of Neurology, 4860 Y Street, Suite 3700
🇺🇸Sacramento, California, United States
University of South Florida, 4 Columbia Drive, Suite 410
🇺🇸Tampa, Florida, 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
UCLA Medical Center, 710 Westwood Plaza, A-253
🇺🇸Los Angeles, California, United States
The Parkinson's Institute, 675 ALMANOR AVENUE
🇺🇸Sunnyvale, California, United States
Movement Disorders Program, Department of Neurology, Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510
🇺🇸Littleton, Colorado, United States
University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
🇺🇸Baltimore, Maryland, United States
Boston University Medical Center, Department of Neurology, 715 Albany Street C329
🇺🇸Boston, Massachusetts, United States
Johns Hopkins, 601 North Caroline Street, Suite 5064
🇺🇸Baltimore, Maryland, United States
Beth Israel Medical Center, 10 Union Square East, Suite 5Hh2
🇺🇸New York, New York, United States
University Neurology Inc., 222 Piedmont Avenue, Suite 3200
🇺🇸Cincinnati, Ohio, United States
Penn State Milton S Hershey Med Center, Department of Neurology Mc H109 Room 2846, 500 University Drive Po Box 850
🇺🇸Hershey, Pennsylvania, United States
Booth Gardner Parkinson'S Care Center, 13030 121St Way North East Suite 203
🇺🇸Kirkland, Washington, United States
Un of Calgary Movement Disorders Program, Dept of Clin Neurosciences Area 3 Neurology, 3350 Hospital Dr NW Health Sciences Centre
🇨🇦Calgary, Alberta, Canada
Ohio State University Medical Center, 1581 Dodd Drive, 371 McCampbell Hall
🇺🇸Columbus, Ohio, United States
Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr, 47 New Scottland Avenue
🇺🇸Albany, New York, United States
The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204
🇺🇸Fountain Valley, California, United States
University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive
🇺🇸La Jolla, California, United States
University of Vermont , Department of Neurology Given Building C-219 , 89 Beaumont Avenue
🇺🇸Burlington, Vermont, United States
University of California Irvine, 100 Irvine Hall
🇺🇸Irvine, California, United States
University of Toledo , 3000 Arlington Avenue , Mail Stop 1195
🇺🇸Toledo, Ohio, United States
Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213
🇺🇸Brooklyn, New York, United States
University of Alberta Glenrose Rehab Hosp, Rm 0601 Glen East, 10230 - 111 Avenue
🇨🇦Edmonton, Alberta, Canada
London Health Sciences Centre, University Campus Room 10N29, 339 Windermere Road
🇨🇦London, Ontario, Canada
The Ottawa Hospital-Civic Campus, 1053 Carling Avenue C2 Room 2210
🇨🇦Ottawa, Ontario, Canada
Lsuhsc Shreveport, Department of Neurology, 1501 Kings Highway Room 3-436
🇺🇸Shreveport, Louisiana, United States
The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B
🇺🇸New Haven, Connecticut, United States
University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
🇺🇸Charleston, South Carolina, United States
Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept of Neurology 7Th Floor
🇺🇸New Orleans, Louisiana, United States
JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S
🇺🇸Bronx, New York, United States