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About
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of SD-809 extended release (ER) in participants switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long-term treatment with SD-809 ER will be assessed in "Switch" participants as well as "Rollover" participants completing a randomized, double blind, placebo-controlled study of SD-809 ER.
Enrollment
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Inclusion criteria
Participant is at least 18 years of age or the age of majority (whichever is older) at Screening.
Participant has been diagnosed with manifest HD, as indicated by characteristic motor exam features, and has a documented expanded cytosine adenine guanine (CAG) repeat (greater than or equal to >= [37]) at or before Screening.
Participant meets either of the following:
Participant has a Total Functional Capacity (TFC) score >=5 at Screening.
Participant is able to swallow study medication whole.
Participant has provided written, informed consent or, a legally authorized representative (LAR) has provided written informed consent and the subject has provided assent.
Participant has provided a Research Advance Directive.
Female participants of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
The participant has a reliable caregiver who interacts with the participant on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required.
Participant is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (such as; walker, cane) are permitted during ambulation).
Has sufficient reading skills to comprehend the participant completed rating scales.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
119 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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