Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

First Time Use of SD-809 in Huntington Disease (First-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.
ClinicalTrials.gov Identifier: NCT01795859
Recruitment Status : Completed
First Posted : February 21, 2013
Results First Posted : August 11, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE February 20, 2013
First Posted Date  ICMJE February 21, 2013
Results First Submitted Date  ICMJE May 5, 2017
Results First Posted Date  ICMJE August 11, 2017
Last Update Posted Date September 20, 2017
Actual Study Start Date  ICMJE August 5, 2013
Actual Primary Completion Date December 5, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 [ Time Frame: Screening, Day 0, Weeks 9, 12 ]
Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
Total Maximal Chorea Score (TMC) [ Time Frame: 3 weeks ]
Change History Complete list of historical versions of study NCT01795859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • 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: Baseline, 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First Time Use of SD-809 in Huntington Disease
Official Title  ICMJE A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chorea
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2014)
90
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2013)
100
Actual Study Completion Date  ICMJE December 5, 2014
Actual Primary Completion Date December 5, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01795859
Other Study ID Numbers  ICMJE SD-809-C-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date August 2017

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