Clinical trial NCT00740714: Effects of Coenzyme Q10 (CoQ) in Parkinson Disease
Official title: Effects of Coenzyme Q10 in Parkinson Disease - Phase III
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: Parkinson disease
PD
Coenzyme Q10
CoQ
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Rochester
First posted: 2008-08-25
Enrollment: 600
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))
timeFrame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Secondary outcomes:
measure: Change in Modified Schwab & England Independence Scale From Baseline to 16 Months
timeFrame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
measure: Change in Modified Rankin Scale From Baseline to 16 Months
timeFrame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
measure: Change in PD Quality of Life Scale From Baseline to 16 Months
timeFrame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
measure: Change in Symbol Digit Modalities Test From Baseline to 16 Months
timeFrame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
measure: Change in Hoehn & Yahr Score From Baseline to 16 Months
timeFrame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
measure: CoQ10 Levels in Plasma
timeFrame: Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
measure: Adverse Experiences: Back Pain
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Constipation
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Insomnia
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Anxiety
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Tremor
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Nasopharyngitis
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Diarrhoea
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Headache
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Urinary Tract Infection
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Nausea
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Hypertension
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Depression
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Constipation: Moderate/Severe
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Anxiety: Moderate/Severe
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Back Pain: Moderate/Severe
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
measure: Adverse Experiences: Insomnia: Moderate/Severe
timeFrame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B
state: Arizona
city: Sun City
country: United States
facility: Sunhealth Research Institute, 10515 West Santa Fe Drive
state: Arizona
city: Fountain Valley
country: United States
facility: The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204
state: California
city: Irvine
country: United States
facility: University of California Irvine, 100 Irvine Hall
state: California
city: La Jolla
country: United States
facility: University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center, 710 Westwood Plaza, A-253
state: California
city: Sacramento
country: United States
facility: UC Davis Dept of Neurology, 4860 Y Street, Suite 3700
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute, 675 ALMANOR AVENUE
state: California
city: Aurora
country: United States
facility: Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511
state: Colorado
city: Littleton
country: United States
facility: Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510
state: Colorado
city: New Haven
country: United States
facility: The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B
state: Connecticut
city: Gainsville
country: United States
facility: University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100
state: Florida
city: Miami
country: United States
facility: University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5
state: Florida
city: Tampa
country: United States
facility: University of South Florida, 4 Columbia Drive, Suite 410
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
state: Georgia
city: Augusta
country: United States
facility: Movement Disorders Program, Department of Neurology, Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University, 710 North Lake Shore Drive
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center Department of Neurological Sciences, 1725 West Harrison Suite 755
state: Illinois
city: Chicago
country: United States
facility: University of Chicago, 5841 South Maryland Avenue, Mc2030
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard
state: Kansas
city: Louisville
country: United States
facility: University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept of Neurology 7Th Floor
state: Louisiana
city: Shreveport
country: United States
facility: Lsuhsc Shreveport, Department of Neurology, 1501 Kings Highway Room 3-436
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins, 601 North Caroline Street, Suite 5064
state: Maryland
city: Elkridge
country: United States
facility: Parkinson & Movement Dis Center If Maryland, 8180 Lark Brown Road, Suite 101
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center, Department of Neurology, 715 Albany Street C329
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 809D
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota, 420 Delaware Street SE, Mmc 295
state: Minnesota
city: St Louis
country: United States
facility: Washington University School of Medicine, 660 South Euclid, Box 8111
state: Missouri
city: Albany
country: United States
facility: Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr, 47 New Scottland Avenue
state: New York
city: Bronx
country: United States
facility: JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S
state: New York
city: Brooklyn
country: United States
facility: Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213
state: New York
city: Manhasset
country: United States
facility: Northshore-Lij Health System, the Feinstein Institute Fpr Medical Research, 350 Community Drive Room 100
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center, 10 Union Square East, Suite 5Hh2
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Room 5Ho1
state: New York
city: New York
country: United States
facility: Parkinson'S Dis & Movement Disorders Inst, 428 East 72Nd Street, Suite 400
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell
state: New York
city: New York
country: United States
facility: Columbia University, 710 West 168Th Street, 3Rd Floor
state: New York
city: Rochester
country: United States
facility: University of Rochester Department of Neurology, 919 Westfall Road Building C Suite 220
state: New York
city: Durham
country: United States
facility: Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213
state: North Carolina
city: Cincinnati
country: United States
facility: University Neurology Inc., 222 Piedmont Avenue, Suite 3200
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center, 1581 Dodd Drive, 371 McCampbell Hall
state: Ohio
city: Toledo
country: United States
facility: University of Toledo , 3000 Arlington Avenue , Mail Stop 1195
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University, Dept of Neurology, 3181 SW Sam Jackson Park Road Op-32
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S Hershey Med Center, Department of Neurology Mc H109 Room 2846, 500 University Drive Po Box 850
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania, Pennsylvania Hospital Department of Neurology, 330 South 9Th Street
state: Pennsylvania
city: Warwick
country: United States
facility: Neurohealth Parkinson'S Disease, Movement Disorder Center, 227 Centerville Road
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
state: South Carolina
city: Memphis
country: United States
facility: Semmes Murphey Clinic, 1211 Union Avenue, Suite 200
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine - Parkinson'S, Disease Center and Movement Disorders Clinic, 65501 Fannin St, Suite 1801
state: Texas
city: Burlington
country: United States
facility: University of Vermont , Department of Neurology Given Building C-219 , 89 Beaumont Avenue
state: Vermont
city: Kirkland
country: United States
facility: Booth Gardner Parkinson'S Care Center, 13030 121St Way North East Suite 203
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Department of Neurology, 9200 West Wisconsin Avenue
state: Wisconsin
city: Calgary
country: Canada
facility: Un of Calgary Movement Disorders Program, Dept of Clin Neurosciences Area 3 Neurology, 3350 Hospital Dr NW Health Sciences Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Glenrose Rehab Hosp, Rm 0601 Glen East, 10230 - 111 Avenue
state: Alberta
city: London
country: Canada
facility: London Health Sciences Centre, University Campus Room 10N29, 339 Windermere Road
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital-Civic Campus, 1053 Carling Avenue C2 Room 2210
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, Univ Health Network, 399 Bathurst Street Mc 7-402, Movement Disorders Centre
state: Ontario
city: Montreal
country: Canada
facility: CHUM-HOPITAL NOTRE DAME, 1560 rue SHERBROOKE est ROOM GR 1185, PAVILLON DECHAMPS etage rez-de-chaussee
state: Quebec
city: Sherbrooke
country: Canada
facility: University of Sherbrooke, 3001 12E Avenue Nord
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital, 103 Hospital Drive, Room 1663
state: Saskatchewan
city: Quebec
country: Canada
facility: Quebec Memory and Motor Skills Dis Clinic, Price Building 3Rd Floor, 65 Sainte-Anne Street
Study officials:
affiliation: Weill Medical College of Cornell University, New York Hospital Department of Neurology
name: M. Flint Beal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester, Department of Biostatistics
name: David Oakes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester, Clinical Trials Coordination Center
name: Ira Shoulson, MD
role: PRINCIPAL_INVESTIGATOR
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