Alternatives for Reducing Chorea in HD (ARC-HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01897896
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Auspex Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of SD-809 ER in subjects 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" subjects as well as "Rollover" subjects completing a randomized, double blind, placebo controlled study of SD-809 ER,

Condition or disease Intervention/treatment Phase
Chorea Associated With Huntington Disease Drug: SD-809 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long Term Safety Study of SD-809 ER in Subjects With Chorea Associated With Huntington Disease
Actual Study Start Date : November 12, 2013
Primary Completion Date : August 21, 2017
Study Completion Date : August 21, 2017

Arm Intervention/treatment
Experimental: Switch Subject Cohort
Switch subjects are those who are currently receiving stable doses of tetrabenazine for treatment of chorea associated with HD and convert to SD-809 ER based on an algorithm designed to achieve comparable exposure to total (α+β)-HTBZ metabolites.
Drug: SD-809
SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.
Other Name: deutetrabenazine
Experimental: Rollover Subject Cohort
Rollover subjects are those who have successfully completed Study SD-809-C-15 and are continuing on long-term SD-809 ER after a 1-week wash out period.
Drug: SD-809
SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.
Other Name: deutetrabenazine

Primary Outcome Measures :
  1. Overall incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal [ Time Frame: Duration of study ]
  2. Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during the titration period in Rollover subjects [ Time Frame: Up to 8 weeks ]
  3. Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during the dose adjustment period in Switch subjects [ Time Frame: Up to 4 weeks ]
  4. Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal during long term treatment [ Time Frame: From Week 3 to end of study ]

Secondary Outcome Measures :
  1. Changes from baseline in clinical laboratory parameters (hematology, chemistry and urinalysis) [ Time Frame: Duration of study ]
  2. Changes from baseline in UHDRS, UPDRS (dysarthria), BARS, HADS, ESS, C-SSR, and MoCA [ Time Frame: Duration of study ]
  3. Changes from baseline in vital signs [ Time Frame: Duration of study ]
  4. Changes from baseline in ECG parameters and abnormal findings [ Time Frame: Duration of study ]
  5. Duration of time to achieve stable dosing of SD-809 ER [ Time Frame: Up to 4 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is at least 18 years of age or the age of majority (whichever is older) at Screening.
  2. Subject has been diagnosed with manifest HD, as indicated by characteristic motor exam features, and has a documented expanded CAG repeat (≥ 37) at or before Screening.
  3. Subject meets either of the following:

    • Has successfully completed participation in the First-HD Study (SD-809-C-15) OR
    • Has been receiving an FDA-approved dose of tetrabenazine that has been stable for ≥ 8 weeks before Screening and is providing a therapeutic benefit for control of chorea.
  4. Subject has a Total Functional Capacity (TFC) score ≥ 5 at Screening.
  5. Subject is able to swallow study medication whole.
  6. Subject has provided written, informed consent or, a legally authorized representative (LAR) has provided written informed consent and the subject has provided assent.
  7. Subject has provided a Research Advance Directive.
  8. Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
  9. 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.
  10. Subject is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (i.e., walker, cane) are permitted during ambulation).
  11. Has sufficient reading skills to comprehend the subject completed rating scales.

Exclusion Criteria:

  1. Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
  2. Subject has active suicidal ideation at Screening or Baseline.
  3. Subject has history of suicidal behavior at Screening or Baseline.
  4. Subject has evidence for depression at Baseline.
  5. Subject has an unstable or serious medical illness at Screening or Baseline.
  6. Subject has received tetrabenazine within 7 days of Baseline (Rollover subjects only).
  7. 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 (Rollover subjects only)

      • Switch subjects may receive Memantine if on a stable, approved dose for at least 30 days
  8. Subject has significantly impaired swallowing function at Screening or Baseline.
  9. Subject has significantly impaired speaking at Screening or Baseline.
  10. Subject requires treatment with drugs known to prolong the QT interval.
  11. Subject has prolonged QT interval on 12-lead ECG at Screening.
  12. Subject has evidence of hepatic impairment at Screening.
  13. Subject has evidence of significant renal impairment at Screening.
  14. Subject has known allergy to any of the components of study medication.
  15. Subject 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.
  16. Subject is pregnant or breast-feeding at Screening or Baseline.
  17. Subject acknowledges present use of illicit drugs at Screening or Baseline.
  18. Subject has a history of alcohol or substance abuse in the previous 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01897896

  Hide Study Locations
United States, Alabama
Teva Investigational Site 057
Birmingham, Alabama, United States, 35233
United States, Arkansas
Teva Investigational Site 298
Fayetteville, Arkansas, United States, 72703
United States, Colorado
Teva Investigational Site 052
Englewood, Colorado, United States, 80113
United States, District of Columbia
Teva Investigational Site 333
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Teva Investigational Site 160
Gainesville, Florida, United States, 32607
Teva Investigational Site 014
Miami, Florida, United States, 33136
United States, Georgia
Teva Investigational Site 032
Atlanta, Georgia, United States, 30329
United States, Indiana
Teva Investigational Site 045
Indianapolis, Indiana, United States, 46202
United States, Iowa
Teva Investigational Site 024
Iowa City, Iowa, United States, 52242
United States, Kansas
Teva Investigational Site 029
Kansas City, Kansas, United States, 66160
Teva Investigational Site 083
Wichita, Kansas, United States, 67226
United States, Kentucky
Teva Investigational Site 087
Louisville, Kentucky, United States, 40202
United States, Maryland
Teva Investigational Site 028
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Teva Investigational Site 040
Boston, Massachusetts, United States, 02118
United States, Missouri
Teva Investigational Site 027
Saint Louis, Missouri, United States, 63110
United States, Nevada
Teva Investigational Site 194
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Teva Investigational Site 328
Camden, New Jersey, United States, 08103
Teva Investigational Site 026
New Brunswick, New Jersey, United States, 08901
United States, New York
Teva Investigational Site 037
Albany, New York, United States, 12208
Teva Investigational Site 002
New York, New York, United States, 10032
Teva Investigational Site 342
Patchogue, New York, United States, 11772
United States, North Carolina
Teva Investigational Site 119
Durham, North Carolina, United States, 27705
United States, Ohio
Teva Investigational Site 089
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Teva Investigational Site 341
Tulsa, Oklahoma, United States, 74136
United States, Tennessee
Teva Investigational Site 031
Nashville, Tennessee, United States, 37232-2551
United States, Texas
Teva Investigational Site 007
Houston, Texas, United States, 77030
Teva Investigational Site 199
Houston, Texas, United States, 77030
United States, Utah
Teva Investigational Site 100
Salt Lake City, Utah, United States, 84108
United States, Vermont
Teva Investigational Site 137
Burlington, Vermont, United States, 05401
United States, Washington
Teva Investigational Site 220
Kirkland, Washington, United States, 98034
Teva Investigational Site 096
Seattle, Washington, United States, 98108
Teva Investigational Site 098
Montreal, Canada, H2L4M1
Teva Investigational Site 231
Ottawa, Canada, K1G 3G4
Teva Investigational Site 300
Toronto, Canada, M2K 1E1
Sponsors and Collaborators
Auspex Pharmaceuticals, Inc.
Study Director: Teva Medical Expert, MD TEVA

Responsible Party: Auspex Pharmaceuticals, Inc. Identifier: NCT01897896     History of Changes
Other Study ID Numbers: SD-809-C-16
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Teva Pharmaceutical Industries ( Auspex Pharmaceuticals, Inc. ):
Huntington Disease

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms