The effects of coenzyme Q10 (CoQ) in early Parkinson’s disease phase III trial is underway. Information gained from this trial could lead to changes in management of people with early Parkinson’s disease. A Phase III trial is a randomized controlled multicenter trial of the treatment given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
CoQ is a vitamin-like substance involved in key biochemical reactions that produce energy in cells. CoQ levels are reported to be low in patients with Parkinson’s disease.
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 Parkinson’s disease. The findings also suggested that CoQ could slow the progressive impairment of Parkinson’s disease as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS). Less disability developed in subjects assigned to coenzyme Q10 than in those assigned to placebo, and the benefit was greatest in subjects receiving the highest dosage.
Parkinson’s disease is a progressive neurodegenerative disease that affects more than 1,000,000 Americans. There is currently no proven therapy to reduce the rate of progression of Parkinson’s disease.
In this Phase III study, researchers are conducting a randomized, placebo-controlled 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 Parkinson’s disease. The study also will evaluate independent function, cognition, and quality of life.
This study is currently recruiting participants. More information on this study can be found at ClinicalTrial.gov using the trial identifier NCT00740714.
References:
1. Shults CW, et al. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol. 2002 Oct;59(10):1541-50. PMID: 12374491.
2. M. Flint Beal, et al. Weill Medical College of Cornell University. ClinicalTrials.gov Identifier: NCT00740714.
3. National Institutes of Health.
