Recruiting

Deutetrabenazine

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06997198

Conditions

Tardive Dyskinesia

Intellectual Disability

Developmental Disabilities

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deutetrabenazine Oral Capsule

Study Details

Brief summary:

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). Compare global deutetrabenazine treatment response with validated instruments.

In addition, we plan to:

  • Assess the safety of deutetrabenazine in the treatment of TD in persons with IDD.
  • Assess change in Activities of Daily Living (ADLs) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated ADL instrument.
  • Assess change in Quality of Life (QOL) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated QOL instrument.
  • Assess caregiver burden with a validated caregiver burden instrument.

In this study, 25 participants with IDD and TD will undergo Deutetrabenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks.

This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to deutetrabenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication. This will be an open-label, Phase 4 study.

Conditions

Tardive Dyskinesia

Intellectual Disability

Developmental Disabilities

Study ID

NCT06997198

Start date

Jun 22, 2026

Status verified date

Jul, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Deutetrabenazine

This an open-label study in which all participants will have their Deutetrabenazine dose titrated from 12 mg to 24 mg per day, which will remain the Deutetrabenazine dose through end of study, unless interrupted by adverse events. Participants taking Deutetrabenazine who are concurrently taking strong CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, duloxetine) will continue their Deutetrabenazine dose at 24 mg per day through end of study.

Interventions

Deutetrabenazine Oral Capsule

Open-label twenty-four-week treatment with Deutetrabenazine oral tablets (up to 24 mg/day) to test the safety and effectiveness of this medication in ameliorating the signs of tardive dyskinesia in persons with intellectual disability.

Primary outcome measure

  • Change in AIMS total scores of items 1-7 [ Time Frame: Baseline and 24 weeks from start of treatment ]

Central Contacts and Locations

Central contacts

Melissa Stasko, JD, MA

216-370-2090melissa.stasko@case.edu

Locations

University Hospitals of Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Melissa Stasko

216-370-2090melissa.stasko@case.edu

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • movement disorders
  • antipsychotic medication adverse effects
  • Abnormal Involuntary Movement Scale
  • quality of life
  • adaptive behavior
  • caregiver burden
  • deutetrabenazine
  • selective vesicular monoamine transporter 2 inhibitor
  • VMAT2 inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-07-06.