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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jan 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called deutetrabenazine to see how it affects speech and walking difficulties in people with Huntington Disease (HD). The goal is to find out if this drug can help improve the ability to speak clearly and walk more effectively in individuals who have been diagnosed with HD.

To be eligible for the study, participants need to be between 65 and 74 years old, have a confirmed diagnosis of Huntington Disease, and show certain levels of movement challenges. They should be able to walk at least 10 meters and have a good understanding of their surroundings. Participants will also be required to give their consent and must be stable in their health condition. If you or someone you know is interested in joining, it’s important to note that certain health issues, like severe depression or unstable medical conditions, may exclude someone from participation. Throughout the trial, participants can expect regular assessments and support from the research team to track any changes in their speech and walking abilities.

Gender

ALL

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