Stay tuned: New clinical trials will be enrolling soon!
It is an exciting time in HD Research! Researchers worldwide have been working diligently to bring more clinical trials than ever before to the HD community.
While this is not a complete list of all the HD research studies that are being planned for 2009, we are able to provide the following information:
IN NORTH AMERICA
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2CARE - THIS TRIAL IS CURENTLY ENROLLING (updated January 2009)
The 2CARE study was launched in March 2008. More information about the large, Coenzyme Q10 study can be found in the Currently Enrolling area of this web site.
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CREST-E (updated January 2009)
This trial is an international multicenter study that will test the safety, tolerability and efficacy of creatine in persons with HD and is scheduled to move ahead. Funding has been secured from the National Center for Complementary and Alternative Medicine (NCCAM) and the FDA Orphan Products Division. Start-up activities are underway. Enrollment is anticipated to begin in first quarter of 2009. Steven Hersch, MD, PhD is the Principal Investigator at Massachusetts General Hospital and Bernard Ravina, MD is the Principal Investigator for the Coordination Center at the University of Rochester. Please see the CREST-E Clinical Trials.Gov web site listing for more information.
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PRECREST - THIS TRIAL IS CURRENTLY ENROLLING (updated January 2009)
This trial is a single-site study being performed at Massachusetts General Hospital that is examining the safety and tolerability of high dose creatine in individuals at risk for HD but not yet symptomatic and assessing the effects of the treatment on neuroimaging and blood biomarkers. The study is supported by The Avicena Group and by NINDS and has been enrolling subjects. Steven Hersch, MD, PhD, is the Principal Investigator, H. Diana Rosas is the enrolling investigator. Please see the PRECREST Clinical Trials.Gov web site listing for more information.
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PREQUEL (updated January 2009)
PREQUEL is a trial to test the tolerability and biological activity of Coenzyme Q10 in pre-manifest HD gene carriers. The National Institutes of Neurological Disorders and Stroke (NINDS) has approved the study and enrollment is anticipated to begin in the Spring 2009. Christopher A Ross, MD, PhD is the principal investigator and Kevin M. Biglan, MD, MPH is the co-principal investigator.
IN EUROPE
Initiating a clinical trial is a timely and multi-stepped process. Two of the most important steps, securing funding and obtaining approval from regulatory and patient protection agencies, can take anywhere from 6 to 24 months to complete. Until these two steps are complete, a study cannot begin.
Below is an overview of the current state of HD research:
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Small, pilot studies are being conducted to assess whether a specific study drug has an effect on HD symptoms. The results of these studies will help to determine if a larger scale clinical trial of the drug is worth pursuing.
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New projects to determine the safety and tolerability of potential study drugs have been proposed by groups working in collaboration with the Huntington Project. These projects are now being reviewed by the FDA. Once the FDA is assured that a study under review will not pose significant harm to the participant, approval to initiate the trials will be granted and enrollment can begin.
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Larger scale studies are awaiting approval from the FDA. These are studies where funding for the study has been secured, however, full regulatory approval from the FDA has not yet been obtained. Huntington Project collaborators continue to meet with the FDA and the funding sources to finalize the regulatory process and get approval to begin these studies.
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The Huntington Project is working in collaboration with our European colleagues, the European HD Network (EHDN) to collaboratively plan and implement collection of natural history data and samples for potential biomarker studies.
The Huntington Project will keep you informed about the latest enrolling HD clinical trials in the coming months. Please continue to check the Currently Enrolling page. New studies will be listed as soon as they are accepting participants.
If you are new to clinical trials, we suggest that you speak with your healthcare providers, family members, or friends who may be able to provide you with information and guidance about participating in a study. For more information about clinical trials for Huntington’s disease, see our Overview page.
The Huntington Study Group may have a research site in your area. Please see Huntington Study Group/HSG Research Sites for contact information. The HSG sites give you access to physicians, nurses, social workers, neuropsychologists and other professionals who specialize in treating Huntington’s disease.
The above trial information may change at any time.
Please check back for updates. Thank you.
Last Update - January 2009