First Time Use of SD-809 in Huntington Disease
Condition: Chorea
MeSH terms: Huntington Disease; Chorea
Intervention: SD-809; Placebo
Intervention description: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).; Placebo tablets are identical in appearance to SD-809 tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Huntington disease; Chorea; Tetrabenazine

Summary:

      The purpose of this study is to determine whether SD-809 tablets are effective in the
      treatment of chorea associated with Huntington's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is at least 18 years of age or the age of majority (whichever is older) at
             Screening.

          -  Subject has been diagnosed with manifest HD

          -  Subject is able to swallow study medication whole.

          -  Female subjects of childbearing potential agree to use an acceptable method of
             contraception from screening through study completion.

          -  The subject has a reliable caregiver who interacts with the patient on a daily basis,
             oversees study drug administration, assures attendance at study visits and
             participates in evaluations, as required.

          -  Subject is able to ambulate without assistance for at least 20 yards (Note: The use of
             assistive devices (i.e., walker, cane) is permitted during ambulation).

        Exclusion Criteria:

          -  Subject has a serious untreated or under-treated psychiatric illness, such as
             depression, at Screening or Baseline.

          -  Subject has active suicidal ideation at Screening or Baseline.

          -  Subject has history of suicidal behavior at Screening or Baseline:

          -  Subject has evidence for depression at Screening or Baseline.

          -  Subject has an unstable or serious medical or psychiatric illness at Screening or
             Baseline.

          -  Subject has been recently exposed to tetrabenazine.

          -  Subject 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

          -  Subject has significantly impaired swallowing function at Screening.

          -  Subject has significantly impaired speaking at Screening.

          -  Subject requires treatment with drugs known to prolong the QT interval.

          -  Subject has a prolonged QT interval on 12-lead ECG at Screening.

          -  Subject has evidence of hepatic impairment at Screening.

          -  Subject has evidence of significant renal impairment at Screening.

          -  Subject has known allergy to any of the components of study medication.

          -  Subject has participated in an investigational drug or device trial within 30 days (or
             5 drug half-lives) of Screening, whichever is longer.

          -  Subject is pregnant or breast-feeding at Screening or Baseline.

          -  Subject acknowledges present use of illicit drugs at Screening.

          -  Subject has a history of alcohol or substance abuse in the previous 12 months.