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

NCT04713982 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 200069
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Examine the effects of deutetrabenazine on functional speech and gait impairment

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (2)

• Sentence Intelligibility Test (SIT)

  SIT is a measure of speech intelligibility that requires the participant to read aloud 11 sentences that increase in length from 5 to 10 words. Speech intelligibility is indexed in terms of percent intelligible. This is determined by calculating the mean number of correct words transcribed from the SIT transcriptions by three unfamiliar listeners and dividing this by the total number of words in the 11-sentence sample.

  Up to 10 weeks

• Motor Speech Evaluation (MSE)

  The MSE will include a set of tasks described by Duffy (2013) that permit consistent rating of perceptual characteristics associated with motor speech disorders. These tasks include vowel prolongation, alternating motion rates, sequential motion rates, and contextual speech (oral reading, picture description, conversational speech). These recordings will be used to complete the perceptual assessment of speech characteristics using the Mayo Clinic classification system.

  Up to 10 weeks

Secondary Outcomes (4)

• 3-D optical motion capture system recording

  Up to 10 weeks

• Functional Joint Kinematics Improvements

  Up to 10 weeks

• Four Square Step Test (FSST)

  Up to 10 Weeks

• Functional Gait Assessment (FGA)

  Up to 10 weeks

Other Outcomes (5)

• Communication Effectiveness Survey

  Up to 10 weeks

• Nine-Hole Peg Test

  Up to 10 weeks

• 10 Meter Walk test

  Up to 10 Weeks

Study Arms (1)

Deutetrabenazine

EXPERIMENTAL

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.

Drug: Deutetrabenazine

Interventions

Deutetrabenazine DRUG

Maximum dose of 48mg/day or up to 36 mg/d if receiving a strong CYP2D6 inhibitor

Also known as: Austedo

Deutetrabenazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Huntington Disease

Interventions

deutetrabenazine

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Amy E Brown, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 19, 2021
• Study Start: November 19, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)