Keywords: Huntington's Disease (HD) , CREST-E , Creatine Treatment Trial , Multi-Center
IRB Number: 00040174
Specialty: Neurology, Neurology, Neurology
Sub Specialties: Movement Disorders, Chorea, Huntington Disease
The is a controlled (double-blind) multi-center Phase III safety, tolerability, and efficacy trial of 40-grams daily creatine in Huntington’s disease (HD) patients. Creatine monohydrate (“creatine”) is a nutritional supplement that can support the production of cellular energy.
The primary goal of this study will be to assess the effects of creatine monohydrate on the progression of functional decline in HD as measured by the annulazied rate of change in the Total Functional Capacity (TFC) scale. Secondarily, we will aim to examine the long term safety and tolerability of creatine monohydrate and to determine whether its effects correspond to measures of bioavailability, improvement of oxidative injury biomarkers, or reduction of brain atrophy. The design of this study will incorporate interim analyses of safety, futility, and efficacy to provide early and repeated safety data for the FDA at high doses and permit early stopping or modification, if necessary.
Main entry requirements include: - Age 18 or older - Early (mild to moderate) HD - Able to provide informed consent - Not taking investigational drug - Additional eligibility criteria apply If you are interested in participating in the CREST‐E study you will first have a visit with the study doctor to determine if you are eligible to participate. This visit will include taking a blood sample, as well as other assessments such as evaluation of your general health, movement and mood. During the study you will be assigned randomly to take either active study drug (creatine) or placebo (looks like study drug but has no active ingredients). You will have a series of regularly scheduled visits and telephone calls to evaluate your general health, movement and mood throughout the study. If you think you might want to participate in the CREST‐E study you can contact your local study research team at the University of Utah.