Coenzyme Q10 (CoQ) in Huntington’s disease (2CARE)
HS 2009-6962, e-MOD 8395
Brain & Nerve
Neal Hermanowicz, MD
To evaluate whether the nutritional supplement Coenzyme Q10 (CoQ10) will slow down the mental decline in Huntington’s disease (HD). In addition this study will evaluate the safety and effectiveness of long-term use of high doses CoQ10. Subjects will be randomly assigned (like the flip of a coin) to receive either 2400 mg of CoQ10 or a matching placebo (a drug that looks like the study drug, but has no active ingredients).
- You are at least 16 years old and have early stage Huntington disease (HD)
- You are able to walk and are fully self-sufficient in activities of daily living, such as eating, dressing and bathing
- If you are female and able to become pregnant, you must agree to use adequate birth control methods
- If you are taking certain disallowed medications, there are restrictions the researchers will discuss with you
- You can take oral medications
- You have a caregiver who is willing to come to the first 2 visits and help monitor your study medication at home
- Because Huntington’s disease is a progressive disease, you will need to select a surrogate decision maker in case in there becomes a time you are no longer able to fully understand the study related procedures
- You are allergic or have a known sensitivity to CoQ10 or any of the ingredients in the study drug
- You have taken another investigational drug within 30 days of study enrollment (at the Baseline Visit)
- You have an unstable or untreated medical illness (i.e. heart, lung, disease) or mental illness (hallucinations, major depression, thoughts of harming yourself
- You have had a problem with alcohol or drug abuse within the past year
- You are a female who is pregnant, breastfeeding, or planning on getting pregnant
- You have used CoQ10 supplements within 120 days prior to study enrollment (at the Baseline visit)
This study will last about 5 years and includes 14 scheduled clinic visits lasting 1-2 hours each and 10 telephone contacts lasting about 15-20 minutes
There is no guarantee of any direct benefit as a result of participating in this study. It is possible that the study drug may be effective in slowing the worsening of Huntington disease, but this cannot be guaranteed.
You will not be paid for your participation in this study.
Shari Niswonger, RN, Department of Neurology