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

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Examine the effects of deutetrabenazine on functional speech and gait impairment

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: Teva Branded Pharmaceutical Products R&D, Inc.

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