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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Deutetrabenazine for Huntington's Disease

Phase 2 & 3

Recruiting

Led By Amy E Brown, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Montreal Cognitive Assessment score ≥ 22 on screening

Diagnosis of HD with documented CAG repeat ≥ 37

Must not have

Unstable or serious medical or psychiatric illness

Severe speech impairment or anarthria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether the drug deutetrabenazine can improve speech and gait in people with movement disorders.

Who is the study for?

This trial is for individuals with Huntington's Disease who can walk at least 10 meters, have a certain level of chorea (involuntary movements), and are cognitively able to participate. They must not be pregnant or breastfeeding, have severe depression or speech impairments, nor any serious medical conditions that could interfere with the study.

What is being tested?

The trial is testing Deutetrabenazine to see if it improves functional speech and walking in people with Huntington's Disease. Participants will receive this medication and their speech and gait dynamics will be monitored for changes.

What are the potential side effects?

Deutetrabenazine may cause side effects such as sleepiness, restlessness, agitation, nausea, dry mouth, and potentially worsen mood disorders like depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cognitive function score is 22 or higher.

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I have Huntington's disease with a CAG repeat of 37 or more.

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I can walk 10 meters without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious or unstable health or mental conditions.

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I have severe difficulty speaking or cannot speak at all.

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I am not pregnant or breastfeeding.

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I do not have severe depression or thoughts of harming myself.

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I am currently taking medication for movement disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Motor Speech Evaluation (MSE)

Sentence Intelligibility Test (SIT)

Secondary study objectives

3-D optical motion capture system recording

Four Square Step Test (FSST)

Functional Gait Assessment (FGA)

+1 more

Other study objectives

10 Meter Walk test

Communication Effectiveness Survey

Health Status

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DeutetrabenazineExperimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met