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A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

NCT07105111 · Neurocrine Biosciences
In plain English

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Official title
A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
About this study
This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.
Eligibility criteria
Key Inclusion Criteria: * 18 years of age or older * Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder * Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening Key Exclusion Criteria: * Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD * Diagnosis of moderate or severe substance use disorder in the last 6 months * History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment
Study design
Enrollment target: 50 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-29
Estimated completion: 2027-01
Last updated: 2026-04-16
Interventions
Drug: Valbenazine
Primary outcomes
  • Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24 (Baseline, Week 24)
Sponsor
Neurocrine Biosciences · industry
Contacts & investigators
ContactNeurocrine Medical Information Call Center · contact · medinfo@neurocrine.com · 1-877-641-3461
InvestigatorClinical Development Lead · study_director, Neurocrine Biosciences
All locations (19)
Neurocrine Clinical SiteRecruiting
Bryant, Arkansas, United States
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Chino, California, United States
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Fountain Valley, California, United States
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Long Beach, California, United States
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Orange, California, United States
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Redlands, California, United States
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San Diego, California, United States
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Bonita Springs, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Orange City, Florida, United States
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Port Charlotte, Florida, United States
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Tampa, Florida, United States
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Marietta, Georgia, United States
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Naperville, Illinois, United States
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Omaha, Nebraska, United States
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Independence, Ohio, United States
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Richmond, Virginia, United States
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor · TrialPath