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New treatment option for Tardive Dyskinesia
Official title Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
ClinicalTrials.gov ID: NCT06997198
What this study is testing
What is Deutetrabenazine Oral Capsule?
Deutetrabenazine Oral Capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tardive dyskinesia.
Also referred to as Austedo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Participant
- 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...
- Eligible to receive deutetrabenazine, according to current product labeling Stable doses of all psychotropic medications for minimum of three months...
- Willing to remain on stable doses of all psychotropics for 24 weeks of study. If female of childbearing age, practicing acceptable form of birth...
You likely can't join if
- 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...
- Any unstable medical condition in the 60 days prior to study entry.
- Pregnant or breast-feeding
- Current or recent hepatic impairment
See the full eligibility criteria
- Participant
- 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
- Able to understand and answer questionnaires
- Able to comply with scheduled visits
- Ability to be primary Caregiver for 24 weeks of study Participant
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.