A Phase 4 interventional study of Valbenazine in Schizophrenia, Schizoaffective Disorder and Bipolar Disorder, sponsored by Neurocrine Biosciences. Recruiting at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Neurocrine Biosciences · Phase 4, Interventional, and Treatment
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 100 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Neurocrine Biosciences is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Valbenazine administered once daily for 24 weeks.
Drug: Valbenazine
Valbenazine capsules for oral administration.
Also known as: NBI-98854
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24
Time frame: Baseline, Week 24
Change from Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24
Time frame: Baseline, Week 24
Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24
Time frame: Baseline, Week 24
Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24
Time frame: Baseline, Week 24
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2028, 34 months after the start.
Of 88 phase 4 interventional studies under Schizophrenia, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 63. This study's planned 34 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Valbenazine