Deutetrabenazine for Tardive Dyskinesia in IDD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 4 interventional study evaluating deutetrabenazine given as an oral capsule to 25 participants with IDD and tardive dyskinesia over 24 weeks. The trial will measure movement disorder response and compare it to published responses in non-IDD populations, using validated scales to assess movement, daily living activities, quality of life, and caregiver burden. Safety will be monitored throughout, with attention to potential changes in ADLs and QOL. Eligible participants have IDD (IQ < 70) and TD for at least 3 months, are on stable psychotropic regimens, and have caregiver support for the duration of the study.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospitals of Cleveland
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Stephen Ruedrich, MD — University Hospitals Cleveland Medical Center
• Study coordinator: Melissa Stasko, JD, MA
• Email: melissa.stasko@case.edu
• Phone: 216-370-2090

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.