Huntington DiseasePhase 2/3NCT04713982
Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
A Phase 2/3 study testing Deutetrabenazine in people with Huntington Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Examine the effects of deutetrabenazine on functional speech and gait impairment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Deutetrabenazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2021to 1 Oct 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Examine the effects of deutetrabenazine on functional speech and gait impairment
Read the 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 production, fine motor skills, gait, and balance both before and after the initiation of deutetrabenazine. The investigators will utilize a variety of standardized, well-validated assessments as well as 3D motion analysis of both speech and gait parameters to determine the functional impact of deutetrabenazine on speech and motor performance.
- Conditions
- Huntington Disease
- Being tested
- Deutetrabenazine
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeutetrabenazineDrug
Also called Austedo
Maximum dose of 48mg/day or up to 36 mg/d if receiving a strong CYP2D6 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Deutetrabenazine | Experimental | The mode of administration is oral. Subjects will be started on deutetrabenazine at a dose of 6mg/day. Dosing will be up-titrated in increments of 6mg/day per week to achieve optimal chorea control. Receives: Drug: Deutetrabenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentence Intelligibility Test (SIT)
SIT is a measure of speech intelligibility that requires the participant to read aloud 11 sentences that increase in length from 5 to 10 words. Speech intelligibility is indexed in terms of percent intelligible. This is determined by calculating the mean number of correct words transcribed from the SIT transcriptions by three unfamiliar listeners and dividing this by the total number of words in the 11-sentence sample.
Measured: Up to 10 weeks
Motor Speech Evaluation (MSE)
The MSE will include a set of tasks described by Duffy (2013) that permit consistent rating of perceptual characteristics associated with motor speech disorders. These tasks include vowel prolongation, alternating motion rates, sequential motion rates, and contextual speech (oral reading, picture description, conversational speech). These recordings will be used to complete the perceptual assessment of speech characteristics using the Mayo Clinic classification system.
Measured: Up to 10 weeks
Secondary outcomes (4)
3-D optical motion capture system recording
To determine the effect of deutetrabenazine on facial movements at rest and during functional task performance (e.g., speaking, chewing) in individuals with HD, the investigators will utilize a 3-D optical motion capture system (Motion Analysis, Ltd.) consisting of six infrared Kestrel cameras with a sensor resolution of 2.2 million pixels at 2,048 x 1,088 full resolution. Facial movements will be captured by placing small (2mm) reflective spheres on each patient's jaw (right/left/center), mouth (right/left corner, upper/lower lip center), and cheeks (right/left zygomatic bone). Further, reflective markers will be placed on the forehead (right/left eyebrows, right/left forehead). Four head markers will serve as reference markers for head movement correction and transposition of all marker movement into a head-based coordinate system.
Measured: Up to 10 weeks
Functional Joint Kinematics Improvements
To determine the effect of deutetrabenazine on joint kinematics and spatiotemporal parameters using 3D motion analysis. Participants will be recording using the Xsens MVN Awinda motion capture system during a 10 meter walk test. Lower- and upper-limb kinematics will be recorded. Wireless sensors will be placed on the ankle, thigh, hand, forearm, bicep, and head. The velocity of the 10 meter walk can be compared to age and gender matched normative values. Gait speed correlates with functional ability, balance and confidence. Three trials are completed, and the average of the three scores is documented. This test will be completed using the 3D motion analysis system.
Measured: Up to 10 weeks
Four Square Step Test (FSST)
The FSST assesses dynamic balance stepping over objects forward, backwards, and sideways. The individual is required to step as fast as possible into each square, requiring the individual to step objects in varying directions. Two tests are completed, with the best time documented as the score.
Measured: Up to 10 Weeks
Functional Gait Assessment (FGA)
The FGA assesses dynamic balance during gait and provides objective information regarding risk of falling. The FGA consists of ten items scored from 0-3, with a maximum total score of 30 points. Items include normal walking, walking with speed changes, walking with head turns, pivot turns, obstacle negotiation, tandem walking, walking with eyes closed, walking backward, and negotiating stairs. Scores less than 23/30 are predictive of falls.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start19 Nov 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Principal investigator, Amy E Brown, Vanderbilt University Medical Center
- Investigators
- Amy E Brown, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713982
- Sponsor's protocol ID
- 200069
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
- ClinicalTrials.gov ID
- NCT04713982
- Acronym / sponsor ID
- 200069
- Conditions
- Huntington Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 production, fine motor skills, gait, and balance both before and after the initiation of deutetrabenazine. The investigators will utilize a variety of standardized, well-validated assessments as well as 3D motion analysis of both speech and gait parameters to determine the functional impact of deutetrabenazine on speech and motor performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deutetrabenazine | Experimental | Drug: DeutetrabenazineThe mode of administration is oral. Subjects will be started on deutetrabenazine at a dose of 6mg/day. Dosing will be up-titrated in increments of 6mg/day per week to achieve optimal chorea control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeutetrabenazineAlso: AustedoMaximum dose of 48mg/day or up to 36 mg/d if receiving a strong CYP2D6 inhibitor | Drug | Deutetrabenazine |
Primary outcome
Sentence Intelligibility Test (SIT)
Time frame: Up to 10 weeks
SIT is a measure of speech intelligibility that requires the participant to read aloud 11 sentences that increase in length from 5 to 10 words. Speech intelligibility is indexed in terms of percent intelligible. This is determined by calculating the mean number of correct words transcribed from the SIT transcriptions by three unfamiliar listeners and dividing this by the total number of words in the 11-sentence sample.
Motor Speech Evaluation (MSE)
Time frame: Up to 10 weeks
The MSE will include a set of tasks described by Duffy (2013) that permit consistent rating of perceptual characteristics associated with motor speech disorders. These tasks include vowel prolongation, alternating motion rates, sequential motion rates, and contextual speech (oral reading, picture description, conversational speech). These recordings will be used to complete the perceptual assessment of speech characteristics using the Mayo Clinic classification system.
4 secondary outcomes
3-D optical motion capture system recording
Time frame: Up to 10 weeks
Functional Joint Kinematics Improvements
Time frame: Up to 10 weeks
Four Square Step Test (FSST)
Time frame: Up to 10 Weeks
Functional Gait Assessment (FGA)
Time frame: Up to 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy E Brown, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Deutetrabenazine in people with Huntington Disease, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentence Intelligibility Test (SIT) (time frame: Up to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.