NCT01834911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

May 28, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

April 15, 2013

Results QC Date

April 9, 2025

Last Update Submit

May 11, 2025

Conditions

Huntington Disease

Keywords

Huntington diseaseHDtetrabenazineStroop

Outcome Measures

Primary Outcomes (1)

  • 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. Patients are analyzed according to Stroop test using Golden's Interference score (theoretical min -50, theoretical max about 98) calculated from \[(W × C)/(W + C)\] - CW, where C=color score (0-100), W=word score (0-100), CW=color word score (0-100). The Interference score analyzes cognitive interference during trials of reading of a list of color words which are printed in a different color. Lower or more negative scores are clinically better as they indicate less interference.

    72 hours

Study Arms (1)

Tetrabenazine withdrawal

EXPERIMENTAL

Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.

Drug: Tetrabenazine withdrawal

Interventions

Tetrabenazine withdrawalDRUG

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.

Tetrabenazine withdrawal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Terence Cardinal Cooke Health Care Center

New York, New York, 10029, United States

Location

Related 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.

    PMID: 22621818BACKGROUND

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Limitations and Caveats

Statistical analysis could not be performed as only one subject was able to provide complete study data.

Results Point of Contact

Title
Dr. Robert Fekete
Organization
New York Medical College
robert_fekete@nymc.edu
9143451313

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 28, 2025

Results First Posted

May 28, 2025

Record last verified: 2025-05

Locations

US(1)