Multiple Sclerosis Clinical Trial

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

Summary

Examine the effects of deutetrabenazine on functional speech and gait impairment

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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.

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Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT04713982

Recruitment Status:

Recruiting

Sponsor:

Vanderbilt University Medical Center

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There is 1 Location for this study

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Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Amy E Brown, MD
Contact
615-936-0060
[email protected]
Amy E Brown, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT04713982

Recruitment Status:

Recruiting

Sponsor:


Vanderbilt University Medical Center

How clear is this clinincal trial information?

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