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First Time Use of SD-809 in Huntington Disease (First-HD)

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries Identifier:
First received: February 20, 2013
Last updated: January 12, 2016
Last verified: January 2016
February 20, 2013
January 12, 2016
July 2013
November 2014   (Final data collection date for primary outcome measure)
Total Maximal Chorea Score (TMC) [ Time Frame: 12 weeks ]
Total Maximal Chorea Score (TMC) [ Time Frame: 3 weeks ]
Complete list of historical versions of study NCT01795859 on Archive Site
  • Treatment Success at the end of therapy as measured by the Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks ]
  • Treatment success at the end of therapy based on Clinical Global Impression of Change (CGIC) [ Time Frame: 12 weeks ]
  • Change in Short Form 36 Health Survey (SF-36) Physical component summary score [ Time Frame: 12 weeks ]
  • Change in Berg Balance Test (BBT) [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
First Time Use of SD-809 in Huntington Disease
A Randomized Double Blind, Placebo Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
The purpose of this study is to determine whether SD-809 ER tablets are effective in the treatment of chorea associated with Huntington's Disease.
This is a randomized, double blind, placebo controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of SD-809 ER for the treatment of chorea associated with Huntington's Disease. Approximately 90 subjects will be randomized (1:1) into the study, with approximately 45 subjects receiving SD-809 ER and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: SD-809
    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).
    Other Name: deutetrabenazine
  • Drug: Placebo
    Placebo tablets are identical in appearance to SD-809 tablets.
  • Experimental: SD-809 ER Tablets
    Intervention: Drug: SD-809
  • Placebo Comparator: SD-809 Placebo
    Intervention: Drug: Placebo
Huntington Study Group, Frank S, Testa CM, Stamler D, Kayson E, Davis C, Edmondson MC, Kinel S, Leavitt B, Oakes D, O'Neill C, Vaughan C, Goldstein J, Herzog M, Snively V, Whaley J, Wong C, Suter G, Jankovic J, Jimenez-Shahed J, Hunter C, Claassen DO, Roman OC, Sung V, Smith J, Janicki S, Clouse R, Saint-Hilaire M, Hohler A, Turpin D, James RC, Rodriguez R, Rizer K, Anderson KE, Heller H, Carlson A, Criswell S, Racette BA, Revilla FJ, Nucifora F Jr, Margolis RL, Ong M, Mendis T, Mendis N, Singer C, Quesada M, Paulsen JS, Brashers-Krug T, Miller A, Kerr J, Dubinsky RM, Gray C, Factor SA, Sperin E, Molho E, Eglow M, Evans S, Kumar R, Reeves C, Samii A, Chouinard S, Beland M, Scott BL, Hickey PT, Esmail S, Fung WL, Gibbons C, Qi L, Colcher A, Hackmyer C, McGarry A, Klos K, Gudesblatt M, Fafard L, Graffitti L, Schneider DP, Dhall R, Wojcieszek JM, LaFaver K, Duker A, Neefus E, Wilson-Perez H, Shprecher D, Wall P, Blindauer KA, Wheeler L, Boyd JT, Houston E, Farbman ES, Agarwal P, Eberly SW, Watts A, Tariot PN, Feigin A, Evans S, Beck C, Orme C, Edicola J, Christopher E. Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):40-50. doi: 10.1001/jama.2016.8655.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2014
November 2014   (Final data collection date for primary outcome measure)

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 has a Total Maximal Chorea Score (TMC) ≥ 8 at Screening and Baseline.
  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. Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
  8. 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.
  9. 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:

  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 Screening or Baseline.
  5. Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
  6. Subject has been recently exposed to tetrabenazine.
  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
  8. Subject has significantly impaired swallowing function at Screening.
  9. Subject has significantly impaired speaking at Screening.
  10. Subject requires treatment with drugs known to prolong the QT interval.
  11. Subject has a 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 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.
  18. Subject has a history of alcohol or substance abuse in the previous 12 months.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   United States
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Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Not Provided
Teva Pharmaceutical Industries
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP