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Trial record 1 of 1 for:    first-hd
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First Time Use of SD-809 in Huntington Disease (First-HD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01795859
First Posted: February 21, 2013
Last Update Posted: September 20, 2017
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.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
Results First Submitted: May 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chorea
Interventions: Drug: SD-809
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 90 subjects were randomized 1:1 to receive either SD-809 or placebo. All subjects were assessed for capacity to provide informed consent and written informed consent was obtained appropriately

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
SD-809 Tablets 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).
SD-809 Placebo Placebo: Placebo tablets are identical in appearance to SD-809 tablets.

Participant Flow:   Overall Study
    SD-809 Tablets   SD-809 Placebo
STARTED   45   45 
COMPLETED   44   43 
NOT COMPLETED   1   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SD-809 Tablets 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).
SD-809 Placebo Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Total Total of all reporting groups

Baseline Measures
   SD-809 Tablets   SD-809 Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   45   90 
Age, Customized 
[Units: Participants]
Mean (Standard Deviation)
     
SD-809   55.4  (10.32)   52.1  (13.36)   53.7  (11.98) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  51.1%      17  37.8%      40  44.4% 
Male      22  48.9%      28  62.2%      50  55.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      5  11.1%      5   5.6% 
White      45 100.0%      38  84.4%      83  92.2% 
More than one race      0   0.0%      2   4.4%      2   2.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)   [ Time Frame: 12 weeks ]

4.  Secondary:   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 ]

5.  Secondary:   Change in Berg Balance Test (BBT)   [ Time Frame: Baseline, 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products R&D, Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01795859     History of Changes
Other Study ID Numbers: SD-809-C-15
First Submitted: February 20, 2013
First Posted: February 21, 2013
Results First Submitted: May 5, 2017
Results First Posted: August 11, 2017
Last Update Posted: September 20, 2017