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Effects of Coenzyme Q10 (CoQ) in Parkinson Disease (QE3)

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Coenzyme Q10 with vitamin E
placebo with vitamin E
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, PD, Coenzyme Q10, CoQ

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
  • Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720
  • Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B
  • Sunhealth Research Institute, 10515 West Santa Fe Drive
  • The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204
  • University of California Irvine, 100 Irvine Hall
  • University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive
  • UCLA Medical Center, 710 Westwood Plaza, A-253
  • UC Davis Dept of Neurology, 4860 Y Street, Suite 3700
  • The Parkinson's Institute, 675 ALMANOR AVENUE
  • Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511
  • Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510
  • The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B
  • University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100
  • University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5
  • University of South Florida, 4 Columbia Drive, Suite 410
  • Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
  • Movement Disorders Program, Department of Neurology, Medical College of Georgia
  • Northwestern University, 710 North Lake Shore Drive
  • Rush University Medical Center Department of Neurological Sciences, 1725 West Harrison Suite 755
  • University of Chicago, 5841 South Maryland Avenue, Mc2030
  • Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
  • University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive
  • The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard
  • University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606
  • Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept of Neurology 7Th Floor
  • Lsuhsc Shreveport, Department of Neurology, 1501 Kings Highway Room 3-436
  • University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
  • Johns Hopkins, 601 North Caroline Street, Suite 5064
  • Parkinson & Movement Dis Center If Maryland, 8180 Lark Brown Road, Suite 101
  • Boston University Medical Center, Department of Neurology, 715 Albany Street C329
  • Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 809D
  • University of Minnesota, 420 Delaware Street SE, Mmc 295
  • Washington University School of Medicine, 660 South Euclid, Box 8111
  • Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr, 47 New Scottland Avenue
  • JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S
  • Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213
  • Northshore-Lij Health System, the Feinstein Institute Fpr Medical Research, 350 Community Drive Room 100
  • Beth Israel Medical Center, 10 Union Square East, Suite 5Hh2
  • Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Room 5Ho1
  • Parkinson'S Dis & Movement Disorders Inst, 428 East 72Nd Street, Suite 400
  • Weill Medical College of Cornell
  • Columbia University, 710 West 168Th Street, 3Rd Floor
  • University of Rochester Department of Neurology, 919 Westfall Road Building C Suite 220
  • Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213
  • University Neurology Inc., 222 Piedmont Avenue, Suite 3200
  • The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31
  • Ohio State University Medical Center, 1581 Dodd Drive, 371 McCampbell Hall
  • University of Toledo , 3000 Arlington Avenue , Mail Stop 1195
  • Oregon Health & Science University, Dept of Neurology, 3181 SW Sam Jackson Park Road Op-32
  • Penn State Milton S Hershey Med Center, Department of Neurology Mc H109 Room 2846, 500 University Drive Po Box 850
  • University of Pennsylvania, Pennsylvania Hospital Department of Neurology, 330 South 9Th Street
  • Neurohealth Parkinson'S Disease, Movement Disorder Center, 227 Centerville Road
  • Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
  • Semmes Murphey Clinic, 1211 Union Avenue, Suite 200
  • Baylor College of Medicine - Parkinson'S, Disease Center and Movement Disorders Clinic, 65501 Fannin St, Suite 1801
  • University of Vermont , Department of Neurology Given Building C-219 , 89 Beaumont Avenue
  • Booth Gardner Parkinson'S Care Center, 13030 121St Way North East Suite 203
  • Medical College of Wisconsin, Department of Neurology, 9200 West Wisconsin Avenue
  • Un of Calgary Movement Disorders Program, Dept of Clin Neurosciences Area 3 Neurology, 3350 Hospital Dr NW Health Sciences Centre
  • University of Alberta Glenrose Rehab Hosp, Rm 0601 Glen East, 10230 - 111 Avenue
  • London Health Sciences Centre, University Campus Room 10N29, 339 Windermere Road
  • The Ottawa Hospital-Civic Campus, 1053 Carling Avenue C2 Room 2210
  • Toronto Western Hospital, Univ Health Network, 399 Bathurst Street Mc 7-402, Movement Disorders Centre
  • CHUM-HOPITAL NOTRE DAME, 1560 rue SHERBROOKE est ROOM GR 1185, PAVILLON DECHAMPS etage rez-de-chaussee
  • University of Sherbrooke, 3001 12E Avenue Nord
  • Royal University Hospital, 103 Hospital Drive, Room 1663
  • Quebec Memory and Motor Skills Dis Clinic, Price Building 3Rd Floor, 65 Sainte-Anne Street

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)

Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)

Placebo (with vitamin E 1200 IU/day)

Outcomes

Primary Outcome Measures

Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))
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

Change in Modified Schwab & England Independence Scale From Baseline to 16 Months
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
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
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
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
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
Based on samples analyzed to date
Adverse Experiences: Back Pain
Number of participants with back pain
Adverse Experiences: Constipation
Number of participants with constipation
Adverse Experiences: Insomnia
Number of participants with insomnia
Adverse Experiences: Anxiety
Number of participants with anxiety
Adverse Experiences: Tremor
Number of participants with tremor
Adverse Experiences: Nasopharyngitis
Number of participants with nasopharyngitis
Adverse Experiences: Diarrhoea
Number of participants with diarrhoea
Adverse Experiences: Headache
Number of participants with headache
Adverse Experiences: Urinary Tract Infection
Number of patients with urinary tract infections
Adverse Experiences: Nausea
Number of participants with nausea
Adverse Experiences: Hypertension
Number of participants with hypertension
Adverse Experiences: Depression
Number of participants with depression
Adverse Experiences: Constipation: Moderate/Severe
Number of participants with moderate/severe constipation
Adverse Experiences: Anxiety: Moderate/Severe
Number of participants with moderate/severe anxiety
Adverse Experiences: Back Pain: Moderate/Severe
Number of participants with moderate/severe back pain
Adverse Experiences: Insomnia: Moderate/Severe
Number of participants with moderate/severe insomnia

Full Information

First Posted
August 22, 2008
Last Updated
December 24, 2012
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00740714
Brief Title
Effects of Coenzyme Q10 (CoQ) in Parkinson Disease
Acronym
QE3
Official Title
Effects of Coenzyme Q10 in Parkinson Disease - Phase III
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
The investigational drug is unlikely to demonstrate efficacy over placebo for this indication. However, no safety issues were discovered.
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, PD, Coenzyme Q10, CoQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
Arm Title
B
Arm Type
Experimental
Arm Description
Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Placebo (with vitamin E 1200 IU/day)
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10 with vitamin E
Other Intervention Name(s)
Coenzyme Q10, ubiquinone, ubidecarenone
Intervention Description
2400 mg dose - eight 300 mg Coenzyme Q10 chewable wafers taken orally four times a day; 1200 mg dose - four 300 mg Coenzyme Q10 and four placebo chewable wafers taken orally four times a day.
Intervention Type
Drug
Intervention Name(s)
placebo with vitamin E
Intervention Description
placebo or an inactive substance (with vitamin E 1200 IU/day); Placebo - eight chewable wafers taken orally four times a day.
Primary Outcome Measure Information:
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))
Description
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.
Time Frame
Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Secondary Outcome Measure Information:
Title
Change in Modified Schwab & England Independence Scale From Baseline to 16 Months
Description
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).
Time Frame
Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Title
Change in Modified Rankin Scale From Baseline to 16 Months
Description
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.
Time Frame
Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Title
Change in PD Quality of Life Scale From Baseline to 16 Months
Description
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.
Time Frame
Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Title
Change in Symbol Digit Modalities Test From Baseline to 16 Months
Description
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).
Time Frame
Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Title
Change in Hoehn & Yahr Score From Baseline to 16 Months
Description
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).
Time Frame
Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Title
CoQ10 Levels in Plasma
Description
Based on samples analyzed to date
Time Frame
Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Title
Adverse Experiences: Back Pain
Description
Number of participants with back pain
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Constipation
Description
Number of participants with constipation
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Insomnia
Description
Number of participants with insomnia
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Anxiety
Description
Number of participants with anxiety
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Tremor
Description
Number of participants with tremor
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Nasopharyngitis
Description
Number of participants with nasopharyngitis
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Diarrhoea
Description
Number of participants with diarrhoea
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Headache
Description
Number of participants with headache
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Urinary Tract Infection
Description
Number of patients with urinary tract infections
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Nausea
Description
Number of participants with nausea
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Hypertension
Description
Number of participants with hypertension
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Depression
Description
Number of participants with depression
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Constipation: Moderate/Severe
Description
Number of participants with moderate/severe constipation
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Anxiety: Moderate/Severe
Description
Number of participants with moderate/severe anxiety
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Back Pain: Moderate/Severe
Description
Number of participants with moderate/severe back pain
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Title
Adverse Experiences: Insomnia: Moderate/Severe
Description
Number of participants with moderate/severe insomnia
Time Frame
Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Flint Beal, MD
Organizational Affiliation
Weill Medical College of Cornell University, New York Hospital Department of Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Oakes, PhD
Organizational Affiliation
University of Rochester, Department of Biostatistics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ira Shoulson, MD
Organizational Affiliation
University of Rochester, Clinical Trials Coordination Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Sunhealth Research Institute, 10515 West Santa Fe Drive
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University of California Irvine, 100 Irvine Hall
City
Irvine
State/Province
California
ZIP/Postal Code
92697-4275
Country
United States
Facility Name
University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0948
Country
United States
Facility Name
UCLA Medical Center, 710 Westwood Plaza, A-253
City
Los Angeles
State/Province
California
ZIP/Postal Code
900095
Country
United States
Facility Name
UC Davis Dept of Neurology, 4860 Y Street, Suite 3700
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
The Parkinson's Institute, 675 ALMANOR AVENUE
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610-5806
Country
United States
Facility Name
University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida, 4 Columbia Drive, Suite 410
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Movement Disorders Program, Department of Neurology, Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University, 710 North Lake Shore Drive
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center Department of Neurological Sciences, 1725 West Harrison Suite 755
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago, 5841 South Maryland Avenue, Mc2030
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept of Neurology 7Th Floor
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Lsuhsc Shreveport, Department of Neurology, 1501 Kings Highway Room 3-436
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins, 601 North Caroline Street, Suite 5064
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0875
Country
United States
Facility Name
Parkinson & Movement Dis Center If Maryland, 8180 Lark Brown Road, Suite 101
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Boston University Medical Center, Department of Neurology, 715 Albany Street C329
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 809D
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Minnesota, 420 Delaware Street SE, Mmc 295
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine, 660 South Euclid, Box 8111
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr, 47 New Scottland Avenue
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Northshore-Lij Health System, the Feinstein Institute Fpr Medical Research, 350 Community Drive Room 100
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Beth Israel Medical Center, 10 Union Square East, Suite 5Hh2
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Room 5Ho1
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Parkinson'S Dis & Movement Disorders Inst, 428 East 72Nd Street, Suite 400
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Medical College of Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University, 710 West 168Th Street, 3Rd Floor
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Department of Neurology, 919 Westfall Road Building C Suite 220
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University Neurology Inc., 222 Piedmont Avenue, Suite 3200
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Medical Center, 1581 Dodd Drive, 371 McCampbell Hall
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Toledo , 3000 Arlington Avenue , Mail Stop 1195
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oregon Health & Science University, Dept of Neurology, 3181 SW Sam Jackson Park Road Op-32
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Penn State Milton S Hershey Med Center, Department of Neurology Mc H109 Room 2846, 500 University Drive Po Box 850
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania, Pennsylvania Hospital Department of Neurology, 330 South 9Th Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Neurohealth Parkinson'S Disease, Movement Disorder Center, 227 Centerville Road
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Semmes Murphey Clinic, 1211 Union Avenue, Suite 200
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Baylor College of Medicine - Parkinson'S, Disease Center and Movement Disorders Clinic, 65501 Fannin St, Suite 1801
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont , Department of Neurology Given Building C-219 , 89 Beaumont Avenue
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Booth Gardner Parkinson'S Care Center, 13030 121St Way North East Suite 203
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Medical College of Wisconsin, Department of Neurology, 9200 West Wisconsin Avenue
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-0099
Country
United States
Facility Name
Un of Calgary Movement Disorders Program, Dept of Clin Neurosciences Area 3 Neurology, 3350 Hospital Dr NW Health Sciences Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4NI
Country
Canada
Facility Name
University of Alberta Glenrose Rehab Hosp, Rm 0601 Glen East, 10230 - 111 Avenue
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Name
London Health Sciences Centre, University Campus Room 10N29, 339 Windermere Road
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
The Ottawa Hospital-Civic Campus, 1053 Carling Avenue C2 Room 2210
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Toronto Western Hospital, Univ Health Network, 399 Bathurst Street Mc 7-402, Movement Disorders Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
CHUM-HOPITAL NOTRE DAME, 1560 rue SHERBROOKE est ROOM GR 1185, PAVILLON DECHAMPS etage rez-de-chaussee
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
University of Sherbrooke, 3001 12E Avenue Nord
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Royal University Hospital, 103 Hospital Drive, Room 1663
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N OW8
Country
Canada
Facility Name
Quebec Memory and Motor Skills Dis Clinic, Price Building 3Rd Floor, 65 Sainte-Anne Street
City
Quebec
ZIP/Postal Code
G1R 3X5
Country
Canada

12. IPD Sharing Statement

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Effects of Coenzyme Q10 (CoQ) in Parkinson Disease

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