A Phase 4 interventional study of Valbenazine in Schizophrenia, Schizoaffective Disorder and Bipolar Disorder, sponsored by Neurocrine Biosciences. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Neurocrine Biosciences · Phase 4, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 59 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Neurocrine Biosciences is the lead sponsor of 85 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.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Valbenazine administered once daily for 24 weeks.
Drug: Valbenazine
Valbenazine capsules for oral administration
Also known as: NBI-98854
Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24
The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact.
Time frame: Baseline, Week 24
Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24
The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item.
Time frame: Baseline, Week 24
Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24
Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health.
Time frame: Baseline, Week 24
Patient Global Impression of Change (PGI-C) Score at Week 24
Participants rated the change in their TD symptoms from the initiation of study treatment dosing by choosing one of 7 responses (1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, and 7=very much worse). Number of participants with PGI-C score responses are reported.
Time frame: Week 24
Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24
The CGI-TD-S is based on a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patients), was used to rate the overall global severity of TD.
Time frame: Baseline, Week 24
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24
The AIMS dyskinesia total score was defined as the sum of the scores of AIMS items 1 through 7. The scores for each item ranged from 0 (no dyskinesia) to 4 (severe dyskinesia). If any of the seven items had a missing value, the total score for that participant/visit was set equal to missing. The AIMS dyskinesia total score can therefore range from 0 to 28, with higher scores indicating greater severity.
Time frame: Baseline, Week 24
| Milestone | Valbenazine |
|---|---|
| Started | 59 |
| Received at least 1 dose of valbenazine | 59 |
| Completed | 51 |
| Not completed | 8 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Other than specified | 2 |
| Withdrew: Withdrawal by subject | 1 |
The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact.
| score on a scale | Valbenazine |
|---|---|
| Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24 | -8.0 (-10.48 to -5.44) |
The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item.
| score on a scale | Valbenazine |
|---|---|
| Item 1: Work/School Impairment | -1.2 (-2.98 to 0.58) |
| Item 2: Social Life Impairment | -2.3 (-3.23 to -1.43) |
| Item 3: Family Life/Home Responsibilities | -1.6 (-2.54 to -0.57) |
Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health.
| score on a scale | Valbenazine |
|---|---|
| Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24 | 13.1 (7.70 to 18.48) |
Participants rated the change in their TD symptoms from the initiation of study treatment dosing by choosing one of 7 responses (1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, and 7=very much worse). Number of participants with PGI-C score responses are reported.
| Participants | Valbenazine |
|---|---|
| 1 = Very Much Improved | 13 |
| 2 = Much Improved | 19 |
| 3 = Minimally Improved | 10 |
| 4 = Not Changed | 2 |
| 5 = Minimal Worse | 1 |
| 6 = Much Worse | 0 |
| 7 = Very Much Worse | 0 |
The CGI-TD-S is based on a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patients), was used to rate the overall global severity of TD.
| score on a scale | Valbenazine |
|---|---|
| Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24 | -1.47 (-1.8 to -1.2) |
The AIMS dyskinesia total score was defined as the sum of the scores of AIMS items 1 through 7. The scores for each item ranged from 0 (no dyskinesia) to 4 (severe dyskinesia). If any of the seven items had a missing value, the total score for that participant/visit was set equal to missing. The AIMS dyskinesia total score can therefore range from 0 to 28, with higher scores indicating greater severity.
| score on a scale | Valbenazine |
|---|---|
| Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24 | -6.8 (-7.75 to -5.81) |
Collected over Up to 26 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Valbenazine | 1/59 (1.7%) | 6/59 (10.2%) | 6/59 (10.2%) |
| Event | Valbenazine |
|---|---|
| Peptic ulcerGastrointestinal disorders | 1/59 |
| Chest painGeneral disorders | 1/59 |
| Medication errorInjury, poisoning and procedural complications | 1/59 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/59 |
| Suicidal ideationPsychiatric disorders | 1/59 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 1/59 |
| Event | Valbenazine |
|---|---|
| NauseaGastrointestinal disorders | 3/59 |
| SomnolenceNervous system disorders | 3/59 |
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Valbenazine |
|---|---|
| Mean | 61.3 ± 11.99 |
| Sex: Female, Male(Participants) | Valbenazine |
|---|---|
| Female | 34 |
| Male | 25 |
| Ethnicity (NIH/OMB)(Participants) | Valbenazine |
|---|---|
| Hispanic or Latino | 24 |
| Not Hispanic or Latino | 35 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Valbenazine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Black or African American | 17 |
| White | 38 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Other | 2 |
| Multiple | 1 |
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