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

Vanderbilt University Medical Center

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Huntington Disease

Treatments: Drug: Deutetrabenazine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04713982

200069

Details and patient eligibility

About

Examine the effects of deutetrabenazine on functional speech and gait impairment

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 study procedures
• Have completed at least 10th grade
• Montreal Cognitive Assessment score ≥ 22 on screening
• Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Deutetrabenazine

Experimental group

Description:

The mode of administration is oral. Subjects will be started on deutetrabenazine at a dose of 6mg/day. Dosing will be up-titrated in increments of 6mg/day per week to achieve optimal chorea control.

Treatment:

Drug: Deutetrabenazine