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Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease

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ClinicalTrials.gov Identifier: NCT01451463
Recruitment Status : Completed
First Posted : October 13, 2011
Results First Posted : October 19, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Lundbeck LLC
Information provided by (Responsible Party):
Sandra Kostyk, Ohio State University

Study Type: Observational
Study Design: Observational Model: Case-Control;   Time Perspective: Prospective
Condition: Huntington's Disease

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Individuals on Stable Doses of Tetrabenazine Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.

Participant Flow:   Overall Study
    Individuals on Stable Doses of Tetrabenazine
STARTED   11 
COMPLETED   11 
NOT COMPLETED   0 



  Baseline Characteristics

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.
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Reporting Groups
  Description
Individuals on Stable Doses of Tetrabenazine 11 Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.

Baseline Measures
   Individuals on Stable Doses of Tetrabenazine 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10  90.9% 
>=65 years      1   9.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.2  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  81.8% 
Male      2  18.2% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Tinetti Mobility Test Score   [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]

2.  Secondary:   Five Times Sit to Stand Test   [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]

3.  Other Pre-specified:   Six Condition Romberg Test   [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Sandra K Kostyk, MD, PhD
Organization: The Ohio State University
phone: 6142934969
e-mail: sandra.kostyk@osumc.edu



Responsible Party: Sandra Kostyk, Ohio State University
ClinicalTrials.gov Identifier: NCT01451463     History of Changes
Other Study ID Numbers: 2010H0312
First Submitted: October 10, 2011
First Posted: October 13, 2011
Results First Submitted: April 23, 2016
Results First Posted: October 19, 2017
Last Update Posted: November 24, 2017