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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01795859
First received: February 20, 2013
Last updated: July 13, 2017
Last verified: July 2017
February 20, 2013
July 13, 2017
August 5, 2013
December 5, 2014   (Final data collection date for primary outcome measure)
Total Maximal Chorea Score (TMC) [ Time Frame: 12 weeks ]
The change in Total Maximal Chorea Score (TMC) from Baseline (defined for each subject as the average of values from the Screening and Day 0 visits) to maintenance therapy (defined for each subject as the average of values from the Week 9 and Week 12 visits). The maximal chorea score is determined from Item 12 of Unified Huntington's Disease Rating Scale and quantifies chorea based on assessments of the face, bucco-orallingual area, trunk, and the four extremities. The total maximal chorea score is a sum of chorea scores in the seven body regions. The scale ranges from 0-28 with a decrease indicating improvement in chorea.
Total Maximal Chorea Score (TMC) [ Time Frame: 3 weeks ]
Complete list of historical versions of study NCT01795859 on ClinicalTrials.gov Archive Site
  • Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks ]
    A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved
  • Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) [ Time Frame: 12 weeks ]
    A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.
  • Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12 [ Time Frame: 12 weeks ]
    Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
  • Change in Berg Balance Test (BBT) [ Time Frame: Baseline, 12 weeks ]
    The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.
  • 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 ]
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 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 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 and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chorea
  • 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
    SD-809 ER tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.
    Interventions:
    • Drug: SD-809
    • Drug: Placebo
  • Experimental: SD-809 Tablets
    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). All are administered three times a day, with the 6 mg final dose is placebo.
    Interventions:
    • Drug: SD-809
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 5, 2014
December 5, 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   United States
 
 
NCT01795859
SD-809-C-15
Yes
Not Provided
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Not Provided
Teva Pharmaceutical Industries
July 2017

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