Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
Purpose
Examine the effects of deutetrabenazine on functional speech and gait impairment
Condition
- Huntington Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Deutetrabenazine |
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. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center
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.