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Sponsors and Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Weill Medical College of Cornell University University of Rochester |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00740714 |
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 |
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Parkinson Disease |
Drug: Coenzyme Q10 with vitamin E Drug: placebo with vitamin E |
Phase III |
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 |
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 |
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A: Experimental
Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
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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.
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B: Experimental
Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
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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.
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C: Placebo Comparator
Placebo (with vitamin E 1200 IU/day)
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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.
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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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Parkinson Study Group | 1-888-887-3774 |
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 |
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 |
Parkinson disease PD Coenzyme Q10 CoQ |
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 |
Antioxidants Molecular Mechanisms of Pharmacological Action Vitamins Growth Substances Physiological Effects of Drugs |
Nervous System Diseases Micronutrients Protective Agents Pharmacologic Actions |