Effect of Tetrabenazine on Stroop Interference in HD

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by New York Medical College
Information provided by (Responsible Party):
Robert Fekete, New York Medical College
ClinicalTrials.gov Identifier:
First received: April 15, 2013
Last updated: March 23, 2016
Last verified: March 2016
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 Intervention Phase
Huntington Disease
Drug: Tetrabenazine withdrawal
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Tetrabenazine on Stroop Interference in Huntington Disease

Resource links provided by NLM:

Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Change in Stroop Interference Score [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 10
Study Start Date: March 2013
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.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Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug.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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834911

Contact: Robert Fekete, MD 9145944293 robert_fekete@nymc.edu
Contact: Robert Fekete, MD 9143451313

United States, New York
Terence Cardinal Cooke Health Care Center Recruiting
New York, New York, United States, 10029
Contact: Katherine Becker, LMSW    212-360-3711      
Principal Investigator: Robert Fekete, MD         
Sub-Investigator: Silky Singh, MD         
Sponsors and Collaborators
New York Medical College
  More Information

Responsible Party: Robert Fekete, Principal Investigator, New York Medical College
ClinicalTrials.gov Identifier: NCT01834911     History of Changes
Other Study ID Numbers: L-10,830 
Study First Received: April 15, 2013
Last Updated: March 23, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by New York Medical College:
Huntington disease

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

ClinicalTrials.gov processed this record on May 25, 2016