Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease

Last updated: February 11, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

2/3

Condition

Dyskinesias

Treatment

Deutetrabenazine

Clinical Study ID

NCT04713982
200069
  • Ages > 18
  • All Genders

Study Summary

Examine the effects of deutetrabenazine on functional speech and gait impairment

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of HD with documented CAG repeat ≥ 37

  • UHDRS total maximal chorea score of ≥ 8

  • Able to walk at least 10 meters

  • Medically stable outpatient, based on the investigator's judgment

  • Willing and able to give written informed consent prior to performing any studyprocedures

  • Have completed at least 10th grade

  • Montreal Cognitive Assessment score ≥ 22 on screening

  • Female subjects of childbearing potential agree to use an acceptable method ofcontraception from screening through study completion

Exclusion

Exclusion Criteria:

  • Severe depression or suicidal ideation

  • History of suicidal behavior

  • Unstable or serious medical or psychiatric illness

  • Renal or hepatic impairment

  • Severe speech impairment or anarthria

  • Inability to swallow study medication

  • Women who are pregnant or breast feeding

  • History of alcohol or substance abuse within the last 12 months

  • Current use of VMAT2 inhibitor (tetrabenazine, deutetrabenazine, valbenazine)

  • Concurrent participation in any other investigational drug trials

  • EKG QTcF> 500 mse

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Deutetrabenazine
Phase: 2/3
Study Start date:
November 19, 2021
Estimated Completion Date:
April 01, 2026

Study Description

This is a two-year, prospective, single-arm study examining the effects of deutetrabenazine on functional speech and gait impairment. Participants will undergo comprehensive evaluations of speech production, fine motor skills, gait, and balance both before and after the initiation of deutetrabenazine. The investigators will utilize a variety of standardized, well-validated assessments as well as 3D motion analysis of both speech and gait parameters to determine the functional impact of deutetrabenazine on speech and motor performance.

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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