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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01834911
Other study ID # L-10,830
Secondary ID
Status Completed
Phase Phase 4
First received April 15, 2013
Last updated March 29, 2018
Start date March 2013
Est. completion date January 1, 2018

Study information

Verified date March 2018
Source New York Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug.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.

Locations

Country Name City State
United States Terence Cardinal Cooke Health Care Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Stroop Interference Score 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. 6 hours
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