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Effect of Tetrabenazine on Stroop Interference in HD

This study is currently recruiting participants.
Verified March 2017 by Robert Fekete, New York Medical College
Sponsor:
ClinicalTrials.gov Identifier:
NCT01834911
First Posted: April 18, 2013
Last Update Posted: March 28, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Fekete, New York Medical College
April 15, 2013
April 18, 2013
March 28, 2017
March 2013
January 1, 2018   (Final data collection date for primary outcome measure)
Change in Stroop Interference Score [ Time Frame: 6 hours ]
Participants will have Stroop Visual Interference Scores measured while OFF tetrabenazine for at least 3 days. Two doses of 12.5 mg tetrabenazine will be subsequently administered: first dose just after the Stroop test and second dose 3 hours later. Stroop Visual Interference Scores will be measured again in the ON state, 6 hours after the initial OFF measurement.
Same as current
Complete list of historical versions of study NCT01834911 on ClinicalTrials.gov Archive Site
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Effect of Tetrabenazine on Stroop Interference in HD
Effect of Tetrabenazine on Stroop Interference in Huntington Disease
Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve postural stability in Huntington disease (HD) patients as measured by computerized dynamic posturography testing. This study aims to elucidate whether partial dopaminergic depletion via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on the Stroop interference test.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Huntington Disease
Drug: Tetrabenazine withdrawal
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test.
Experimental: Tetrabenazine withdrawal
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.
Intervention: Drug: Tetrabenazine withdrawal
Fekete R, Davidson A, Ondo WG, Cohen HS. Effect of tetrabenazine on computerized dynamic posturography in Huntington disease patients. Parkinsonism Relat Disord. 2012 Aug;18(7):896-8. doi: 10.1016/j.parkreldis.2012.04.029. Epub 2012 May 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 1, 2018
January 1, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Established diagnosis of Huntington disease by movement disorders expert
  • Patients currently taking tetrabenazine.
  • Patients should not have taken dopamine receptor blocking medication for at least three days

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Robert Fekete, MD 9145944293 robert_fekete@nymc.edu
Contact: Robert Fekete, MD 9143451313
United States
 
 
NCT01834911
L-10,830
No
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Robert Fekete, New York Medical College
New York Medical College
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Not Provided
New York Medical College
March 2017

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