CREST-E

The Huntington Study Group (HSG) is conducting a research study using high-dose, pharmaceutical grade creatine-monohydrate in persons 18 years or older who have clinical features of Huntington Disease (HD). CREST-E is designed to measure the effects of creatine-monohydrate on the progression of functional decline HD. This research study will also look at the long-term safety, tolerability and effectiveness of treatment with up to 40 g/day of creatine-monohydrate, as compared to a placebo. Additionally, this research will evaluate how a variety of biological processes are affected by the study drug or how they may reflect disease activity or progression. This study will include about 44 research centers around the world and will include 650 with up to 15 subjects at Rush.  Subjects are expected to participate in the study for up to 37 months.

You may be eligible to participate in this study if you:

• Are at least 18 years of age
• Are able to provide written informed consent
• Have clinical features of HD and a confirmation by family history or genetic testing
• Are willing to comply with the study procedures
• Are not pregnant, lactating or intending to become pregnant

You will be excluded from this study if you:

• Have a history of known sensitivity or intolerability to creatine monohydrate
• Have had exposure to any investigational drug within 30 days of randomization (Baseline visit)
• Use supplemental creatine at a dose greater than 10 grams/day within 90 days of randomization (Baseline visit)
• Use supplemental Coenzyme Q10 at a dose greater than 600 milligrams daily within 90 days of randomization (Baseline visit)
• Are found to be using CoQ10 supplements totaling greater than 300mg daily. They are not allowed during the study but may be taken prior to the baseline visit

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.