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The Huntington's Post has received an update from the HSG regarding the "First-HD" Trial. One of
our aims is to bring news and information about studies and trials to our Huntington's disease
What is the HSG?
"The Huntington Study Group (HSG) is an independent not-for-profit network of more than 200
clinical investigators, coordinators, and scientists from 100 participating universities and clinics in the
United States, Canada, Europe, Australia, New Zealand and South America who provide
comprehensive care for Huntington disease (HD) patients and families and carry our multi-center
clinical research including observational studies and controlled clinical trials. The mission of the HSG
is to relieve the burden of illness and develop treatments that make a difference for HD patients and
families." - Huntington Study Group
What is the "First-HD" Trial?
First-HD is a Phase III clinical research trial of an investigational drug called SD-809 Extended
Release (ER) in persons who have a diagnosis of Huntington disease (HD). First-HD will look at how
safe, tolerable and effective SD-809 ER is compared to placebo (inactive drug) in reducing chorea.
First-HD will be enrolling participants across North America (United States and Canada) who have
been diagnosed with HD and who have never taken tetrabenazine (Xenazine ®, Nitoman ®).
Participants will be involved in this trial for approximately 4 months.
The First-HD Trial is being conducted by the Huntington Study Group (HSG) under the leadership of
Samuel Frank, MD, Principal Investigator, (Boston University School of Medicine) and Claudia Testa,
MD, PhD, co-Principal Investigator (Virginia Commonwealth University). Approximately 30 HSG
research sites across the United States and Canada will enroll about 90 people with HD. The study is
sponsored by Auspex Pharmaceuticals, Inc. Please download the site map to find a participating
HSG site near you.
Ira Shoulson MD is Professor of
Neurology, Pharmacology and Human
Science and Director of the Program for
Regulatory Science and Medicine
(PRSM) at Georgetown University. Dr.
Shoulson founded the Parkinson Study
in 1985 and the Huntington Study Group
What is SD-809 ER?
SD-809 ER is an investigational drug with
the same mechanism of action as the FDA
approved tetrabenazine (Xenazine ®,
Nitoman ®). Tetrabenazine is currently
approved in the United States and Canada
for the treatment of chorea. SD-809 ER is
metabolized in your body more slowly than
tetrabenazine, allowing the drug to stay in
your system longer. Because SD-809 ER is
metabolized more slowly than
tetrabenazine, it provides smoother drug
levels and can be given less often than
How do I know if I am eligible to participate in the First-HD trial?
People who answer “yes” to the following may be able to join the First-HD Trial:
- Have you been diagnosed with Huntington disease?
- Do you experience chorea?
- I have never taken tetrabenazine
- Are you at least 18 years old or the age of majority in your State or Province, whichever is older?
- Do you have a caregiver who can come with you to study visits?
- Are you able to swallow medications whole?
For additional information about the "First-HD" Trial, feel free to download and print the poster, site
map, and brochure above, or visit the HSG website. As always, information about all HSG
trials/studies can be found on the international mobile application - Help4HD.
Once again we thank the HSG for everything they do for the international Huntington's disease
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Clinic of your choice!
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|More information about "First-HD"