Effects of Coenzyme Q10 (CoQ) in Parkinson Disease

Phase 3

Terminated

Conditions: Parkinson Disease

Interventions: Drug: Coenzyme Q10 with vitamin E
Drug: 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

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.

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 Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
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Birmingham, Alabama, United States
Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720
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Phoenix, Arizona, United States
Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B
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Scottsdale, Arizona, United States
Sunhealth Research Institute, 10515 West Santa Fe Drive
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Sun City, Arizona, United States
The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204
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Fountain Valley, California, United States
University of California Irvine, 100 Irvine Hall
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Irvine, California, United States
University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive
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La Jolla, California, United States
UCLA Medical Center, 710 Westwood Plaza, A-253
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Los Angeles, California, United States
UC Davis Dept of Neurology, 4860 Y Street, Suite 3700
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Sacramento, California, United States
The Parkinson's Institute, 675 ALMANOR AVENUE
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Sunnyvale, California, United States
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University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
🇺🇸Birmingham, Alabama, United States