Phase 4
N=59
Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
Schizophrenia · Schizoaffective Disorder · Bipolar Disorder · Major Depressive Disorder · Tardive Dyskinesia
Bottom Line
View on ClinicalTrials.gov: NCT05859698 ↗Enrolled (actual)
59
Serious AEs
10.2%
Results posted
Jan 2026
Primary outcome: Primary: Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24 — -8.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Valbenazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neurocrine Biosciences
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24 |
-8.0 | — |
| PRIMARY Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24 |
-1.2; -2.3; -1.6 | — |
| PRIMARY Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24 |
13.1 | — |
| SECONDARY Patient Global Impression of Change (PGI-C) Score at Week 24 |
13; 19; 10; 2; 1; 0 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24 |
-1.47 | — |
| SECONDARY Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24 |
-6.8 | — |
Summary
This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05859698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.