Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities

NCT06997198 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY20250619
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Change in AIMS total scores of items 1-7

  The Abnormal Involuntary Movement Scale (AIMS) has been used for many years as the gold standard for this purpose and the amount of improvement (change in movement intensity, and reduction in AIMS scores) have been assessed clinical significance in rating improvement. A number of authors have noted the difficulty in using the AIMS in persons with IDD who cannot cooperate fully in the examination process. For this reason, some have suggested using videotaped AIMS exams as a methodology for more accurately quantifying change. Videotaping of exams pre- and post-treatment for blind rating of improvement has been a methodology utilized in a number of recent studies of valbenazine. The minimum value of the AIMS total score of items 1-7 is 0 and the maximum value is 49. Higher total AIMS scores mean worse outcomes.

  Baseline and 24 weeks from start of treatment

Secondary Outcomes (7)

• CGI-C

  Baseline and 24 weeks from start of treatment

• CaGI-C

  Baseline and 24 weeks from start of treatment

• Change in ABC-I score

  Baseline and 24 weeks from start of treatment

• Change in W-ADL score

  Baseline and 24 weeks from start of treatment

• Change in Zarit Burden Interview (short version) score

  Baseline and 24 weeks from start of treatment

Other Outcomes (3)

• Change Simpson-Angus Scale for EPS

  Baseline and 24 weeks from start of treatment

• Change in Barnes Akathisia Scale

  Baseline and 24 weeks from start of treatment

• Assessment of electrocardiogram (EKG)-derived QT/QTc intervals

  Baseline and 24 weeks from start of treatment

Study Arms (1)

Deutetrabenazine

EXPERIMENTAL

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.

Drug: Deutetrabenazine Oral Capsule

Interventions

Deutetrabenazine Oral Capsule DRUG

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.

Also known as: Austedo

Deutetrabenazine

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of IDD (IQ \< 70; social/adaptive dysfunction, onset \< age 22) as per DSM-5
• 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.
• Able to understand and answer questionnaires
• Able to comply with scheduled visits
• Ability to be primary Caregiver for 24 weeks of study

You may not qualify 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 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
• Unable to complete questionnaires
• Unable to comply with scheduled visits
• Will not be a primary Caregiver for the 24 weeks of the study

Sponsors & Collaborators

• Teva Pharmaceuticals USA: collaborator
• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

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MeSH Terms

Conditions

Tardive Dyskinesia; Intellectual Disability; Developmental Disabilities; Movement Disorders; Caregiver Burden

Interventions

deutetrabenazine

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Stephen Ruedrich, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Stasko, JD, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: From 12 months after publication until three years afterwards.
• Access Criteria: Any request must be approved by the corresponding author and the principal investigator. Each request will be checked for compatibility with regulatory (institutional review board) requirements as well as compatibility with participant informed consent.

Locations

US (1)