KanekaQ10™ To Be Used In Phase III Clinical Trial On Coenzyme Q10's Effects On Huntington's Disease

Main Category: Huntingtons Disease
Also Included In: Clinical Trials / Drug Trials
Article Date: 05 Jun 2008 - 1:00 PDT

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The Huntington Study Group has launched a Phase III clinical trial, funded by the National Institute of Neurological Disorders and Stroke (part of the National Institutes of Health [NIH]), to determine the effect of the maximum effective dosage of Coenzyme Q10 on cognitive function in individuals with Huntington's Disease (HD). They will also examine the long-term safety of CoQ10. Currently, there is no known cure or effective drug therapy for HD, a genetic, progressive brain disorder that causes uncontrolled movements, cognitive difficulties and emotional disturbances. According to the Huntington's Disease Society of America, more than a quarter of a million Americans have HD or are "at risk" of inheriting the disease from an affected parent.

The potential health benefits of CoQ10 have been studied since its discovery 50 years ago. The substance, which occurs naturally in the body and is involved in cellular energy production, has documented heart and neurological benefits, among others. Research has shown that aging, various medications and certain diseases inhibit the body's ability to produce CoQ10 on its own.

The five-year, double-blind, placebo-controlled study (called the 2CARE Study) will involve 608 patients in 44 centers across the U.S., Canada and Australia. The multi-million-dollar grant from the NIH's National Institute of Neurological Disorders and Stroke was awarded to Massachusetts General Hospital and The University of Rochester. Merit Cudkowicz, MD, MSc (Massachusetts General Hospital), and Michael McDermott, PhD, and Karl Kieburtz, MD, MPH (University of Rochester), will direct the study.

KanekaQ10™, the only CoQ10 manufactured in the U.S., is the sole source of CoQ10 being used in the trial.

"Since there are no FDA-approved drugs currently on the market that slow the functional decline of those suffering from Huntington's, this is an extremely important trial, and Kaneka Nutrients is proud to be involved," said Dr. Robert Barry, Director of Scientific Affairs for Kaneka Nutrients L.P.'s U.S. Operations. "As the purest, most rigorously tested CoQ10 available, KanekaQ10 has been used in all major CoQ10 clinical trials approved by the FDA and funded by the NIH. We're eager to see the trial results since they pose hope for a better quality of life for patients suffering from this debilitating disease."

CoQ10 has been studied in a variety of clinical trials, and no serious safety issues have been reported. The 2CARE study will be the largest therapeutic clinical trial to date focused on Huntington's disease.

About Huntington Study Group

The Huntington Study Group (HSG) is a non-profit group of clinical investigators from medical centers in the United States, Canada, Europe and Australia, experienced in the care of Huntington patients and dedicated to clinical research of Huntington disease.

The HSG was formed in 1993, prompted by the recognition that clinical research in Huntington disease (HD) required the participation of large numbers of research patients (subjects) under the cooperative care of skilled and experienced research physicians. The HSG aims to advance knowledge about the cause(s), disease progression and treatment of HD and related disorders. For more information about the HSG, the 2CARE study and the centers that are currently recruiting for the study, individuals may visit the HSG website at http://www.huntington-study-group.org or call 1-800-487-7671.

About Kaneka Nutrients L.P. and KanekaQ10TM

Kaneka Nutrients, L.P., is the world's leading supplier of CoenzymeQ10 and the only manufacturer producing CoQ10 in the U.S. For more information, visit http://www.KanekaQ10.com.

Kaneka Nutrients L.P.