A phase IIa, randomized, double-blind, placebo-controlled study of the safety and efficacy of fenofibrate as a treatment for Huntington's disease
February 09, 2017
Neal Hermanowicz, MD
Gottschalk Medical Plaza
and Institute for Clinical and Translational Sciences (ICTS), UC Irvine campus
The purpose of this research study is to study the safety and efficacy of fenofibrate, an FDA-approved drug for high cholesterol and/or elevated triglycerides (fats), as a treatment for Huntington's disease (HD).
Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined. The study team will go through study eligibility criteria with you to verify if you qualify for participation in this study.
Inclusion requirements — you can participate in this study if you:
- Are an adult of either sex, ages 25 to 85 inclusive
- Have proficiency with written and spoken English and corrected vision or hearing to complete the cognitive testing
- Are able to give informed consent
- Have good overall health status with no known problems anticipated over the course of the trial
- Have a diagnosis of HD supported by positive gene test within the past 6 months
Exclusion requirements — you cannot participate in this study if you have:
- Other major neurological disease (e.g., multiple sclerosis, Parkinson's disease, cortical stroke)
- Clinically significant hepatic or renal disease
- Current or recent (<1 month) use of specific medications
- Enrollment in another investigational drug study within the prior three months
You will take fenofibrate once a day for six (6) months. You will have monthly follow-up visits, where you will have a fasting blood draw, a brief clinical examination and completion of an adverse events questionnaire. In addition, at the baseline three- and six-month visits, you will complete behavioral questionnaires. The monthly visits will take approximately 30 minutes to one (1) hour.
Taking part in this study may or may not make your health better. While researchers hope fenofibrate will be more effective than the standard (usual) treatment, there is no proof of this yet.
If you are in the group that receives fenofibrate, and it proves to treat your condition more effectively and with fewer side effects than standard therapy or the placebo, you may benefit from participating in the study, but this cannot be guaranteed.
This study will help researchers learn more about fenofibrate, and it is hoped that this information will help in the treatment of future patients with Huntington's disease.
You will not be compensated for your participation in this research study.
Jaclyn Alcazar, Department of Neurology