Status:
ENROLLING_BY_INVITATION
Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Huntington Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 prod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04713982
Start Date
November 19 2021
End Date
April 1 2026
Last Update
October 23 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232