Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Auspex Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
1. Has successfully completed participation in the First-HD Study (SD-809-C-15) or
2. Has been receiving an Food and Drug Administration (FDA)-approved dose of tetrabenazine that has been stable for \>=8 weeks before Screening and is providing a therapeutic benefit for control of chorea.
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.
You may not be if
Participant has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
Participant has active suicidal ideation at Screening or Baseline.
Participant has history of suicidal behavior at Screening or Baseline.
Participant has evidence for depression at Baseline.
Participant has an unstable or serious medical illness at Screening or Baseline.
Participant has received tetrabenazine within 7 days of Baseline (Rollover participants only).
Participant has received any of the following concomitant medications within 30 days of Screening or Baseline: Antipsychotics, Metoclopramide, Monoamine oxidase inhibitors (MAOI), Levodopa or dopamine agonists, Reserpine, Amantadine, Memantine (Rollover participants only)
Switch participants may receive Memantine if on a stable, approved dose for at least 30 days
Participant has significantly impaired swallowing function at Screening or Baseline.
Participant has significantly impaired speaking at Screening or Baseline.
Participant requires treatment with drugs known to prolong the QT interval.
Participant has prolonged QT interval on 12-lead electrocardiogram (ECG) at Screening.
Participant has evidence of hepatic impairment at Screening.
Participant has evidence of significant renal impairment at Screening.
Participant has known allergy to any of the components of study medication.
Participant has participated in an investigational drug or device trial other than SD-809-C-15 within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
Participant is pregnant or breast-feeding at Screening or Baseline.
Participant acknowledges present use of illicit drugs at Screening or Baseline.
Participant has a history of alcohol or substance abuse in the previous 12 months.
Clareo Health | Alternatives for Reducing Chorea in Huntington Disease
