Effects of Coenzyme Q10 (CoQ) in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Coenzyme Q10 with vitamin E; placebo with vitamin E
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.; placebo or an inactive substance (with vitamin E 1200 IU/day); Placebo - eight chewable wafers taken orally four times a day.
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Coenzyme Q10; Ubiquinone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 600.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson disease; PD; Coenzyme Q10; CoQ

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.
    

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.