Deutetrabenazine for Tardive Dyskinesia

(TD-AIDD Trial)

Overseen By Melissa Stasko, JD, MA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University Hospitals Cleveland Medical Center

Must be taking: Psychotropics

Must not be taking: CYP2D6 inhibitors, Anticholinergics

Disqualifiers: Unstable medical condition, Hepatic impairment, Cardiac arrhythmia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stephen Ruedrich, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for individuals with intellectual/developmental disabilities (IDD) and Tardive Dyskinesia (TD), who have stable mental health medication doses, can comply with study visits, and if female of childbearing age, are using birth control. Excluded are those with recent substance abuse, unstable medical conditions, certain heart issues or taking specific medications like strong CYP2D6 inhibitors.

Inclusion Criteria

Diagnosis of IDD (IQ < 70; social/adaptive dysfunction, onset < age 22) as per DSM-5

I agree to not change my mental health medications for 6 months and, if I can have children, to use birth control during the study.

Subject able to comply with scheduled visits and assessments

Exclusion Criteria

History of substance abuse or dependence in the 3 months prior to study entry

Treatment with any investigational drug in the 30 days prior to study entry

Significant risk of suicide or dangerous aggression to others at time of or 3 months prior to study entry

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Deutetrabenazine treatment for Tardive Dyskinesia

24 weeks

5 visits (in-person) at baseline, 3 weeks, 6 weeks, 12 weeks, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Deutetrabenazine

Trial Overview The trial tests Deutetrabenazine Oral Capsule's effectiveness in treating TD in patients with IDD over 24 weeks without a comparison group. It aims to assess safety, impact on daily activities and quality of life improvements as well as caregiver burden through five scheduled visits.

Participant Groups

Group I: Deutetrabenazine Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Teva Pharmaceuticals USA

Industry Sponsor

Trials

232

Recruited

189,000+

Dr. Eric A. Hughes

Teva Pharmaceuticals USA

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Pharmaceuticals USA

Chief Executive Officer since 2023

BSc in Biochemistry from Imperial College London