ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Examine the effects of deutetrabenazine on functional speech and gait impairment

Official Title

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

Quick Facts

Study Start:2021-11-19

Study Completion:2026-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04713982

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Amy E Brown, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Amy E Brown, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-19

Study Completion Date2026-10-01

Study Record Updates

Study Start Date2021-11-19

Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

Huntington Disease