Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease (NCT04713982) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
United States30 participantsStarted 2021-11-19
Plain-language summary
Examine the effects of deutetrabenazine on functional speech and gait impairment
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing deutetrabenazine specifically for speech and walking problems in Huntington's disease — given my current symptoms, does it make sense to discuss whether my speech or gait issues are significant enough that this kind of study could be relevant to my care?
2The trial is in Phase 2/3, which means it's still gathering evidence on how well the treatment works — what do we know so far about deutetrabenazine's safety profile, and are there any side effects I should be especially aware of given my specific situation?
3The trial is listed as 'active, not recruiting,' meaning they're no longer enrolling new patients — are there other ongoing or upcoming studies on deutetrabenazine or similar medications for Huntington's disease that might still be open to me?
4The study is measuring speech intelligibility and motor speech as its main outcomes — if my primary concern is chorea or another symptom rather than speech, would a different treatment path or trial potentially be a better fit for me right now?
5Since deutetrabenazine is already FDA-approved for Huntington's chorea, could I potentially discuss trying it as a standard treatment option outside of a clinical trial, and how would that compare to waiting for trial results?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.