Effects of deutetrabenazine on speech and walking in Huntington Disease
Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
This study tests whether a medication called deutetrabenazine can help improve speech and walking in people with Huntington Disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04713982 on ClinicalTrials.gov |
What this trial studies
This study investigates how deutetrabenazine affects functional speech and gait in individuals diagnosed with Huntington Disease. Over two years, participants will receive comprehensive evaluations of their speech production, fine motor skills, gait, and balance before and after starting the medication. The study employs standardized assessments and advanced 3D motion analysis to measure changes in speech and motor performance, aiming to provide insights into the medication's functional impact.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Huntington Disease who have specific motor and cognitive capabilities.
Not a fit: Patients with severe speech impairment or those currently using VMAT2 inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve speech and mobility in patients with Huntington Disease.
How similar studies have performed: Previous studies on similar interventions have shown promise, but this specific approach with deutetrabenazine is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Amy E Brown, MD — Vanderbilt University Medical Center
- Study coordinator: Amy E Brown, MD
- Email: amy.brown@vumc.org
- Phone: 615.936.0060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.