NEW CLINICAL TRIAL INITIATIVES THERAPEUTIC and OBSERVATIONAL TRIALS
Updated: November 2007
The HSG is funded to conduct a definitive clinical trial of high dose coenzyme Q10 (CoQ) in Huntington’s disease (HD). The HSG-run CARE-HD study (led by Dr. Karl Kieburtz) demonstrated evidence that CoQ might have a potential benefit in slowing the decline of functional capacity in HD. We therefore began the important process to determine the best dosage, obtain funding and obtain FDA approval to conduct a definitive clinical study.
Under the leadership of Drs. Merit Cudkowicz, Michael McDermott, and Karl Kieburtz, a number of meetings have taken place to carefully plan this large, Phase III study, entitled 2CARE. Meetings have occurred with both the FDA, under whose authority our HSG clinical trials are conducted, and the National Institutes of Health, the US federal agency that provides the financial support to conduct many of our studies. The purpose of these meetings has been to work proactively in partnership with these governing bodies to seek their advice and approval to move forward with study initiation.
The initial steps in planning for the 2CARE study (Coenzyme Q10 in Huntington’s Disease), in which several hundred people with HD will be enrolled, included carrying out some smaller, shorter-term studies to determine what the appropriate dosage of CoQ should be in 2CARE. These studies also assessed whether or not the use of CoQ at the selected dosage, which will be much higher than what people typically take when buying CoQ on their own, is safe and does not pose any unnecessary health risks in the short-term. One such HSG study, called Pre-2CARE (Pilot Safety and Tolerability Study of Coenzyme Q10 in Huntington’s Disease and in Normal Subjects), was completed last year (see Research News), and another study, QuBE (Coenzyme Q10 (Ubiquinone) Bioequivalence Study) was also completed. Results for each of these studies have been submitted for publication in a medical journal.
The FDA also requires that additional studies be carried out in animals to demonstrate safety of high dosages over a longer period of time. Drs. Cudkowicz, McDermott, and Kieburtz, along with other HSG investigators, have been involved in discussions with scientists who specialize in designing and carrying out animal studies. Once these plans are approved by the FDA, we will begin enrollment (current estimates are by early 2008). Please continue to visit the HSG web site for further developments as we get closer to starting this exciting new study. When we have FDA approval to conduct the clinical study, more information about the study will be posted, as well as the clinical centers that will be participating and contact names and phone numbers for more information.
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