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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of deutetrabenazine for individuals with Tardive Dyskinesia (TD) who also have intellectual and developmental disabilities (IDD). The study aims to determine if deutetrabenazine improves daily living activities and quality of life while ensuring safety. Participants will receive the medication for 24 weeks and attend five study visits. Those who have not been treated with similar medications before and have had TD for at least three months may be suitable candidates. Without a comparison group, researchers will compare results to previous studies on deutetrabenazine. As a Phase 4 trial, this research seeks to understand how the FDA-approved treatment benefits a broader patient population.

Will I have to stop taking my current medications?

You will need to stay on stable doses of your current psychotropic medications for the entire 24 weeks of the study. However, if you are taking certain medications like strong CYP2D6 inhibitors or other specified drugs, you may need to stop them before joining the trial.

What is the safety track record for deutetrabenazine?

Research has shown that deutetrabenazine is generally safe and effective for treating tardive dyskinesia (TD). Long-term studies have found that patients using deutetrabenazine experience few serious problems. However, common side effects include irritability, fatigue, dry mouth, and depression.

A detailed safety review also noted that excessive sleepiness and suicidal thoughts are possible, though less common. Overall, evidence suggests that most people manage the treatment well, but awareness of these potential side effects is important. Always consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Deutetrabenazine is unique because it specifically targets the involuntary movements associated with tardive dyskinesia by reducing dopamine activity in the brain. This mechanism of action is different from standard treatments like antipsychotics or benzodiazepines, which can sometimes worsen symptoms. Researchers are excited about deutetrabenazine because it offers a focused approach with the potential for fewer side effects, making it a promising alternative for those who haven't found relief with existing therapies.

What is the effectiveness track record for deutetrabenazine in treating tardive dyskinesia?

Research has shown that deutetrabenazine effectively treats tardive dyskinesia (TD), a condition causing involuntary movements. In earlier studies, over 94% of patients reported improved movement after using the treatment. Additionally, about two-thirds of patients experienced at least a 50% reduction in symptoms. The treatment has proven effective for long-term relief of TD symptoms, with many patients expressing high satisfaction with the results. Overall, deutetrabenazine effectively reduces the unwanted movements associated with TD. ^{5 6 7 8 9}

Who Is on the Research Team?

Stephen Ruedrich, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ir.tevapharm.com ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Patients-Taking-AUSTEDO-XR-deutetrabenazine-extended-release-tablets-Reported-Symptom-Improvement-and-High-Satisfaction/default.aspx

Patients Taking AUSTEDO XR® (deutetrabenazine) extended ... Of the 209 patients with tardive dyskinesia (TD) that were surveyed, >94% reported movement improvement once treated with AUSTEDO XR® ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8906841/

Long-Term Deutetrabenazine Treatment for Tardive ... Treatment with deutetrabenazine showed robust, clinically meaningful, sustained reductions in dyskinesia, with two-thirds of patients achieving ≥50% and ~40% of ...

3. uspharmacist.com uspharmacist.com/article/study-explores-tardive-dyskinesia-outcomes-with-deutetrabenazine-use

Study Explores Tardive Dyskinesia Outcomes With ... In this interim analysis of data from 131 respondents, results revealed that 87% reported satisfaction with the medication overall, and 74% ...

4. austedohcp.com austedohcp.com/tardive-dyskinesia/clinical-trials-and-studies

Clinical & Real-World Data | Tardive Dyskinesia (TD) ≥50% improvement in AIMS score through Week 145. At Week 145, 67. Consistent results across subgroups: Elderly and younger patients. Mood disorder subgroup

5. tevausa.com tevausa.com/news-and-media/press-releases/teva-announces-long-term-efficacy-and-safety-of-deutetrabenazine-in-european-patients-with-debilitating-m/

Teva Announces Long Term Efficacy and Safety of ... Deutetrabenazine treatment of patients with Tardive Dyskinesia (TD) was associated with long term improvement of TD symptoms.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11846250/

Real-world safety analysis of deutetrabenazine post-marketing The drug's label-listed adverse reactions, including depression, somnolence, suicidal ideation, and fatigue, showed remarkable signals.

7. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1498215/full

real-world adverse event analysis from the FAERS database In this study, a pharmacovigilance analysis of deutetrabenazine was performed based on the FDA Adverse Event Reporting System (FAERS) database to evaluate its ...

8. jnnp.bmj.com jnnp.bmj.com/content/90/12/1317

Long-term safety and efficacy of deutetrabenazine for ... Overall, long-term treatment with deutetrabenazine was efficacious, safe, and well tolerated in patients with TD.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38557959/

Safety of Deutetrabenazine for the Treatment of Tardive ... Common AEs (≥ 4%) included irritability, fall, depression, dry mouth, and fatigue. Conclusions: Data from an integrated analysis of studies in ...