First-HD and ARC-HD are clinical trials investigating a new drug, SD-809 ER (Extended Release), in people who have chorea associated Huntington disease (HD).
Only one drug, tetrabenazine, has been approved by the FDA for the treatment of chorea associated with Huntington disease (HD).
Now is the time for the HD community to rise to the challenge and participate in the creation of potential alternatives in the treatment of chorea. Partner with the Huntington Study Group (HSG) and First-HD clinical research team to help find another potential treatment for chorea.
The First-HD and ARC-HD trials are 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) with sponsorship from Auspex Pharmaceuticals.
What is SD-809 ER?
SD-809 ER is an investigational drug with the same mechanism of action as tetrabenazine. Tetrabenazine is approved by the US Food and Drug Administration (Xenazine®) and Health Canada (Nitoman®) for the treatment of HD related chorea.
The drug in the SD-809 ER tablet releases more slowly and is broken down by the body more slowly than tetrabenazine. These differences may mean that: 1) the drug may be taken fewer times per day than tetrabenazine; 2) a lower dose may be as effective at controlling chorea; and 3) improve how well the body reacts to the drug, compared to tetrabenazine, with potentially less side effects plus good chorea control.
What are the Basic Study Procedures?
In-person and phone visits will occur throughout the study. During your in-person visits, you will undergo a number of tests to see how your HD symptoms are doing. You will have a physical exam and neurological exam, safety labs and undergo an ECG. Your Huntington disease symptoms will be assessed. You will be asked questions about your mood, sleep and restlessness.
What are the Benefits of Participating?
For ethical reasons, monetary compensation cannot be offered for your participation in a clinical trial. However, we can offer reimbursement for study visit travel and/or lodging expenses for participants and their caregivers. Please discuss this with the site nearest you.
Perhaps your largest potential benefit is your satisfaction in knowing that your commitment may help us find an improved treatment for chorea, and bring new treatment options to the HD community.
Participants in ARC-HD may be eligible to receive study drug and medical supervision at no cost for up to 12 months.
What are the Common Eligibility Criteria?
People who answer “yes” to the following may be able to join either trial:
- Have you been diagnosed with Huntington disease and have chorea?
- 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?
What is First-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 not taken tetrabenazine (Xenazine ®, Nitoman ®) in the last six months. Participants will be involved in this trial for approximately 4 months.
Approximately 30 HSG research sites across the United States and Canada will enroll about 90 people with HD. Some First-HD subjects may be eligible to rollover and continue in ARC-HD.
What is ARC-HD?
The ARC-HD trial will determine how safe and tolerable SD-809 ER is in subjects who are currently taking tetrabenazine to treat chorea and “switch” to SD-809 ER.
ARC-HD will enroll subjects who are currently taking tetrabenazine and “roll-over” subjects from First-HD.
Subjects who qualify for the study will be switched from tetrabenazine to a dose of SD-809 ER that is approximately comparable to their tetrabenazine dose. The dose of SD-809 ER can then be adjusted over 4 weeks, if necessary. Remember that all participation in research is voluntary and you may reconsider participating at any time in order to change back to tetrabenazine.
If you are interested in participating in the ARC-HD study and have successfully completed the First-HD trial, you will be started on therapy with SD-809 ER. Subjects will be involved in this trial for up to 14 months and will remain on study drug for a total of 54 weeks.
How can I learn more about the First & ARC trials?
Toll-free (N. America): 800-487-7671