What side effects are associated with this type of intervention?

The most common treatments for Tardive Dyskinesia include VMAT2 inhibitors such as Valbenazine and Deutetrabenazine. Known side effects of these medications can include drowsiness, fatigue, dry mouth, and constipation. Additionally, some patients may experience depression, anxiety, and insomnia. It is important to monitor for these side effects and discuss them with a healthcare provider to manage and mitigate any adverse effects effectively.

What prior FDA approvals exist?

Valbenazine (Ingrezza) was the first VMAT2 inhibitor approved by the FDA in 2017 for the treatment of Tardive Dyskinesia. Another VMAT2 inhibitor, Deutetrabenazine (Austedo), was subsequently approved in 2017 for the same indication. Both drugs work by inhibiting the vesicular monoamine transporter 2 (VMAT2), which helps regulate dopamine release in the brain, thereby reducing the symptoms of TD.

What other types of research exist?

Promising alternatives to Valbenazine for Tardive Dyskinesia include Deutetrabenazine, another VMAT2 inhibitor, which has shown efficacy and safety in clinical trials. Additionally, neuromodulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct-current stimulation (tDCS) are emerging as potential treatments for TD, with studies indicating their effectiveness in reducing symptoms.

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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Valbenazine for Tardive Dyskinesia

Verified Trial

Phase 4

Waitlist Available

Research Sponsored by Neurocrine Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder

Have a clinical diagnosis of neuroleptic-induced TD

Must not have

Are you a significant risk for suicidal or violent behavior?

Do you have a diagnosis of moderate or severe substance use disorder within the last 6 months?

Timeline

Screening 3 days

Treatment Varies

Follow Up baseline, week 24

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test how well valbenazine improves quality of life and functioning in people with tardive dyskinesia over several months. Valbenazine is approved to treat tardive dyskinesia (TD) in adults.

Who is the study for?

This trial is for adults with tardive dyskinesia, a movement disorder often related to long-term use of certain psychiatric medications. Participants must be stable outpatients with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder and on a steady medication regimen. Those with more prominent involuntary movements not due to TD or significant unstable medical conditions are excluded.

What is being tested?

The study tests the effectiveness of valbenazine over a period of up to 24 weeks. It focuses on how well valbenazine improves the quality of life, functioning, and perceived treatment effect in patients as reported by both themselves and their clinicians.

What are the potential side effects?

While specific side effects for this trial aren't listed here, common side effects of valbenazine may include sleepiness, balance issues (risk of falls), restlessness (akathisia), dry mouth, and blurred vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder.

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I have been diagnosed with TD due to antipsychotic medication.

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I have been on a stable dose of medication for my mental health condition for the last 30 days.

Select...

I am 18 years old or older.

Select...

I have been diagnosed with TD due to neuroleptics for over three months.

Select...

I have been diagnosed with Schizophrenia, Schizoaffective, Bipolar Disorder, or MDD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ baseline, week 24

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~baseline, week 24

This trial's timeline: 3 days for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in the EQ-visual analogue scale (EQ-VAS) score at Week 24

Change from baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 at Week 24

Change from baseline in the Tardive Dyskinesia Impact Scale (TDIS) total score at Week 24

Secondary study objectives

Change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at Week 24

Change from baseline in the Clinical Global Impression of Severity - TD (CGI-TD-S) score at Week 24

Patient Global Impression of Change (PGI-C) score at Week 24

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ValbenazineExperimental Treatment1 Intervention

Valbenazine administered once daily for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Valbenazine

2018

Completed Phase 4

~880

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Tardive Dyskinesia (TD) include VMAT2 inhibitors such as Valbenazine and Deutetrabenazine. These medications work by inhibiting the vesicular monoamine transporter 2 (VMAT2), which reduces the release of dopamine in the brain. This is crucial because TD is often caused by long-term use of antipsychotic medications that increase dopamine activity, leading to involuntary movements. By decreasing dopamine release, VMAT2 inhibitors help alleviate these symptoms. Understanding these mechanisms is important for TD patients as it provides a targeted approach to managing their condition, potentially improving their quality of life and reducing the severity of involuntary movements.