New study aims to help people with disabilities suffering from uncontrollable movements
NCT ID NCT06997198
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests a drug called deutetrabenazine for tardive dyskinesia (uncontrollable movements) in 25 adults with intellectual/developmental disabilities and psychiatric or behavioral disorders. Participants will take the medication for 24 weeks to see if it reduces movement problems and improves daily life. The goal is to find a safe and effective treatment for this group, who often have trouble with standard movement exams.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Participant Inclusion Criteria: * Diagnosis of IDD (IQ \< 70; social/adaptive dysfunction, onset \< age 22) as per DSM-5 * Clinical diagnosis of Tardive Dyskinesia (TD) per DSM-5 for at least 3 months before study inclusion (presence of movement disorder for at least 3 months, in absence of previous formal diagnosis of TD). * Eligible to receive deutetrabenazine, according to current product labeling Stable doses of all psychotropic medications for minimum of three months before study inclusion * Willing to remain on stable doses of all psychotropics for 24 weeks of study. If female of childbearing age, practicing acceptable form of birth control throughout study duration. * Subject able to comply with scheduled visits and assessments * Consent of subject, or legally authorized representative to study protocol. Caregiver Inclusion Criteria: * Able to understand and answer questionnaires * Able to comply with scheduled visits * Ability to be primary Caregiver for 24 weeks of study Participant Exclusion Criteria: * Previous treatment with a VMAT2 inhibitor (tetrabenazine, valbenazine, or deutetrabenazine). * Treatment with any investigational drug in the 30 days prior to study entry. * Currently taking a strong CYP2D6 inhibitor such as fluoxetine, paroxetine, quinidine, bupropion. Current treatment with strong anticholinergic agents, monoamine oxidase inhibitors, metoclopramide, dopamine agonists, L-DOPA, or stimulants within past 30 days, or botulinum toxin within the past 3 months. * Any unstable medical condition in the 60 days prior to study entry. * Pregnant or breast-feeding * Current or recent hepatic impairment * History of neuroleptic malignant syndrome * History of long QTc on electrocardiogram, bundle branch block (BBB), atrioventricular block, serious cardiac arrhythmia, or heart failure. QTc on EKG \> 450 msec (Fredericia formula) on EKG within 3 months prior to study entry. * History of substance abuse or dependence in the 3 months prior to study entry. * Significant risk of suicide or dangerous aggression to others at time of or 3 months prior to study entry. * Inability to take study medications Caregiver Exclusion Criteria: * Unable to complete questionnaires * Unable to comply with scheduled visits * Will not be a primary Caregiver for the 24 weeks of the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospitals of Cleveland
RECRUITINGCleveland, Ohio, 44106, United States
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