Valbenazine shows promise for easing involuntary movements in tardive dyskinesia
NCT ID NCT05859698
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 4 study tested valbenazine in 59 adults with tardive dyskinesia (involuntary muscle movements) caused by psychiatric medications. Participants had schizophrenia, bipolar disorder, or major depression. Over 24 weeks, researchers measured changes in quality of life, daily functioning, and overall health using patient and clinician reports. The goal was to see if valbenazine reduces the impact of these movements on everyday life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- valbenazine
- What this could lead to
- If successful, valbenazine could offer a well-tolerated option to reduce the impact of tardive dyskinesia on daily life and emotional well-being.
- What could go wrong
- This is a small, single-arm, open-label study with no placebo group, so results may be less reliable. Tardive dyskinesia can be persistent, and not everyone may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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59 people
The number who actually took part.
- Started
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May 2023
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * At least 18 years of age * 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 * Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study * Participants must be outpatients and have a stable psychiatric status Key Exclusion Criteria: * Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD * Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Neurocrine Clinical Site
Bryant, Arkansas, 72022, United States
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Neurocrine Clinical Site
Anaheim, California, 92805, United States
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Neurocrine Clinical Site
Orange, California, 92868, United States
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Neurocrine Clinical Site
Torrance, California, 90504, United States
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Neurocrine Clinical Site
Bonita Springs, Florida, 34134, United States
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Neurocrine Clinical Site
Miami, Florida, 33176, United States
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Neurocrine Clinical Site
Miami Lakes, Florida, 33016, United States
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Neurocrine Clinical Site
Okeechobee, Florida, 34972, United States
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Neurocrine Clinical Site
Tampa, Florida, 33629, United States
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Neurocrine Clinical Site
Atlanta, Georgia, 30328, United States
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Neurocrine Clinical Site
Augusta, Georgia, 30912, United States
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Neurocrine Clinical Site
Marietta, Georgia, 30060, United States
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Neurocrine Clinical Site
Lincoln, Nebraska, 68526, United States
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Neurocrine Clinical Site
Beechwood, Ohio, 44122, United States
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Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112, United States
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Neurocrine Clinical Site
DeSoto, Texas, 75115, United States
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Neurocrine Clinical Site
El Paso, Texas, 79902, United States
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Neurocrine Clinical Site
Houston, Texas, 77030, United States
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