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Effects of Coenzyme Q10 (CoQ) in Parkinson Disease (QE3)
This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), December 2008
Sponsors and Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Weill Medical College of Cornell University
University of Rochester
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00740714
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Drug: Coenzyme Q10 with vitamin E
Drug: placebo with vitamin E
Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Coenzyme Q10
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Effects of Coenzyme Q10 in Parkinson Disease - Phase III

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Change in UPDRS total score (sum of parts I, II and III) [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Modified Schwab & England Scale [ Time Frame: Screening, Baseline, 1, 4, 8, 12 and 16 month visits ] [ Designated as safety issue: Yes ]
  • Modified Rankin Scale [ Time Frame: Baseline and 16 month visits ] [ Designated as safety issue: Yes ]
  • PD Qualify of Life Scale [ Time Frame: Baseline, 1, 4, 8, 12 and 16 month visits ] [ Designated as safety issue: Yes ]
  • Symbol Digit Modalities Test [ Time Frame: Baseline and 16 month visits ] [ Designated as safety issue: Yes ]
  • Adverse experiences and abnormal lab values [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: December 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
Drug: Coenzyme Q10 with vitamin E
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.
B: Experimental
Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
Drug: Coenzyme Q10 with vitamin E
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.
C: Placebo Comparator
Placebo (with vitamin E 1200 IU/day)
Drug: placebo with vitamin E
placebo or an inactive substance (with vitamin E 1200 IU/day); Placebo - eight chewable wafers taken orally four times a day.

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740714

Contacts
Contact: Parkinson Study Group 1-888-887-3774

  Show 69 Study Locations
Sponsors and Collaborators
Weill Medical College of Cornell University
University of Rochester
Investigators
Principal Investigator: M. Flint Beal, MD Weill Medical College of Cornell University, New York Hospital Department of Neurology
Principal Investigator: David Oakes, PhD University of Rochester, Department of Biostatistics
Principal Investigator: Ira Shoulson, MD University of Rochester, Clinical Trials Coordination Center
  More Information

Publications:
Beal MF, Henshaw DR, Jenkins BG, Rosen BR, Schulz JB. Coenzyme Q10 and nicotinamide block striatal lesions produced by the mitochondrial toxin malonate. Ann Neurol. 1994 Dec;36(6):882-8.
Beal MF, Matthews RT, Tieleman A, Shults CW. Coenzyme Q10 attenuates the 1-methyl-4-phenyl-1,2,3,tetrahydropyridine (MPTP) induced loss of striatal dopamine and dopaminergic axons in aged mice. Brain Res. 1998 Feb 2;783(1):109-14.
Beal MF. Energetics in the pathogenesis of neurodegenerative diseases. Trends Neurosci. 2000 Jul;23(7):298-304. Review.
Beal MF. Coenzyme Q10 as a possible treatment for neurodegenerative diseases. Free Radic Res. 2002 Apr;36(4):455-60. Review.
The NINDS NET-PD Investigators. A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease. Neurology. 2007 Jan 2;68(1):20-8.
Ravina BM, Fagan SC, Hart RG, Hovinga CA, Murphy DD, Dawson TM, Marler JR. Neuroprotective agents for clinical trials in Parkinson's disease: a systematic assessment. Neurology. 2003 Apr 22;60(8):1234-40. Review.
Shoulson, I, et al. Impact of sustained deprenyl (selegiline) in levodopa-treated Parkinson disease: A randomized, placebo-controlled extension of the deprenyl and tocopherol antioxidative therapy of parkinsonism trial. Annals of Neurology, 2002; 51:124-35.
Shults CW, Haas RH, Passov D, Beal MF. Coenzyme Q10 levels correlate with the activities of complexes I and II/III in mitochondria from parkinsonian and nonparkinsonian subjects. Ann Neurol. 1997 Aug;42(2):261-4.
Shults CW, Beal MF, Fontaine D, Nakano K, Haas RH. Absorption, tolerability, and effects on mitochondrial activity of oral coenzyme Q10 in parkinsonian patients. Neurology. 1998 Mar;50(3):793-5.
Shults CW, Oakes D, Kieburtz K, Beal MF, Haas R, Plumb S, Juncos JL, Nutt J, Shoulson I, Carter J, Kompoliti K, Perlmutter JS, Reich S, Stern M, Watts RL, Kurlan R, Molho E, Harrison M, Lew M; Parkinson Study Group. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol. 2002 Oct;59(10):1541-50.
Shults CW. CoQ in neurodegenerative diseases. Curr Med Chem 2003; 10(19):1917-21.
Shults CW, Flint Beal M, Song D, Fontaine D. Pilot trial of high dosages of coenzyme Q10 in patients with Parkinson's disease. Exp Neurol. 2004 Aug;188(2):491-4.
Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial. JAMA. 2005 Jul 6;294(1):56-65.
Blatt DH, Pryor WA. High-dosage vitamin E supplementation and all-cause mortality. Ann Intern Med. 2005 Jul 19;143(2):150-1; author reply 156-8. No abstract available.
McDonald SR, Sohal RS, Forster MJ. Concurrent administration of coenzyme Q10 and alpha-tocopherol improves learning in aged mice. Free Radic Biol Med. 2005 Mar 15;38(6):729-36.
Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. Epub 2004 Nov 10. Summary for patients in: Ann Intern Med. 2005 Jan 4;142(1):I40.
Meydani SN, Lau J, Dallal GE, Meydani M. High-dosage vitamin E supplementation and all-cause mortality. Ann Intern Med. 2005 Jul 19;143(2):153; author reply 156-8. No abstract available.
[No authors listed] Effects of tocopherol and deprenyl on the progression of disability in early Parkinson's disease. The Parkinson Study Group. N Engl J Med. 1993 Jan 21;328(3):176-83.
Shults CW, Oakes D, Kieburtz K, Beal MF, Haas R, Plumb S, Juncos JL, Nutt J, Shoulson I, Carter J, Kompoliti K, Perlmutter JS, Reich S, Stern M, Watts RL, Kurlan R, Molho E, Harrison M, Lew M; Parkinson Study Group. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol. 2002 Oct;59(10):1541-50.

Responsible Party: Weill Medical College of Cornell University ( M. Flint Beal, MD )
Study ID Numbers: U01NS050324
Study First Received: August 22, 2008
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00740714  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Parkinson disease
PD
Coenzyme Q10
CoQ

Study placed in the following topic categories:
Tocopherol acetate
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Alpha-Tocopherol
Coenzyme Q10
Tocopherols
Vitamin E
Parkinson Disease
Movement Disorders
Ubiquinone
Parkinsonian Disorders

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Vitamins
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009