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Effect of Tetrabenazine on Stroop Interference in HD

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ClinicalTrials.gov Identifier: NCT01834911
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Fekete, New York Medical College

Brief 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.

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: Tetrabenazine withdrawal Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Tetrabenazine on Stroop Interference in Huntington Disease
Actual Study Start Date : March 2013
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tetrabenazine withdrawal
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.
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Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug.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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834911


Locations
United States, New York
Terence Cardinal Cooke Health Care Center
New York, New York, United States, 10029
Sponsors and Collaborators
New York Medical College
  Study Documents (Full-Text)

Documents provided by Robert Fekete, New York Medical College:

Publications:
Responsible Party: Robert Fekete, Principal Investigator, New York Medical College
ClinicalTrials.gov Identifier: NCT01834911     History of Changes
Other Study ID Numbers: L-10,830
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

Keywords provided by Robert Fekete, New York Medical College:
Huntington disease
HD
tetrabenazine
Stroop

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs