Clinical trial NCT04713982: Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
Official title: Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Huntington Disease
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2021-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Examine the effects of deutetrabenazine on functional speech and gait impairment

Detailed 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.

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

Primary outcomes:
measure: Sentence Intelligibility Test (SIT)
timeFrame: Up to 10 weeks
measure: Motor Speech Evaluation (MSE)
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: 3-D optical motion capture system recording
timeFrame: Up to 10 weeks
measure: Functional Joint Kinematics Improvements
timeFrame: Up to 10 weeks
measure: Four Square Step Test (FSST)
timeFrame: Up to 10 Weeks
measure: Functional Gait Assessment (FGA)
timeFrame: Up to 10 weeks
Other outcomes:
measure: Communication Effectiveness Survey
timeFrame: Up to 10 weeks
measure: Nine-Hole Peg Test
timeFrame: Up to 10 weeks
measure: 10 Meter Walk test
timeFrame: Up to 10 Weeks
measure: Health Status
timeFrame: Up to 10 weeks
measure: The Functional Assessment of Chronic Illness Therapy (FACIT) scale
timeFrame: Up to 10 weeks
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Amy E Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: