Effect of Tetrabenazine on Stroop Interference in HD

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by New York Medical College
Sponsor:
Information provided by (Responsible Party):
Robert Fekete, New York Medical College
ClinicalTrials.gov Identifier:
NCT01834911
First received: April 15, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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 2014 (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Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.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Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug.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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

-

  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

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

Locations
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

Additional Information:
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
Study First Received: April 15, 2013
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Tetrabenazine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014