INTERVENTIONALCOMPLETEDNCT05859698

A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-01-16

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE4
Enrollment: 59 (ACTUAL)
Start date: 2023-05-09
Sponsor: Neurocrine Biosciences
Design: NA · SINGLE GROUP · TREATMENT
Locations: 18
Results record: Present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Depressive Disorder Bipolar Disorder

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Valbenazine

Valbenazine capsules for oral administration

NBI-98854

Source-reported results

Results posted to the registry

6 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 3
Secondary outcomes: 3
Statistical analyses: 0
Adverse-event terms: 8

PRIMARYChange From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24

Time frame: Baseline, Week 24
Measure: MEAN · score on a scale
Reporting status: POSTED

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.

Population: The Full Analysis Set included all enrolled participants with at least one baseline efficacy data point for any measure and at least one postbaseline efficacy data point for any measure. Here, "Overall Number of Participants Analyzed" = the number of participants evaluable at the timepoint assessed.

Group	N	Value	Spread / interval
Valbenazine	45	-8.0	-10.48 to -5.44

PRIMARYChange From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24

Time frame: Baseline, Week 24
Measure: MEAN · score on a scale

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

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

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

primary outcomes

primary measures

Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24

Time frame: Baseline, Week 24

Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24

Time frame: Baseline, 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.

Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24

Time frame: Baseline, 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.

secondary outcomes

secondary measures

Patient Global Impression of Change (PGI-C) Score at Week 24

Time frame: 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.

Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24

Time frame: Baseline, 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.

Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24

Time frame: Baseline, 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.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 4d91df9e-3510-4784-93a5-f41403b648a3
Retrieved: 11/09/2026, 14:14:52
SHA-256: bbd318a4b2f37b197ebe2fa066846e3891cb9fab878cb5fcecf5bf982372ab90

Event	System	Groups: affected / at risk
Peptic ulcer	Gastrointestinal disorders	Valbenazine: 1 / 59
Chest pain	General disorders	Valbenazine: 1 / 59
Medication error	Injury, poisoning and procedural complications	Valbenazine: 1 / 59
Road traffic accident	Injury, poisoning and procedural complications	Valbenazine: 1 / 59
Suicidal ideation	Psychiatric disorders	Valbenazine: 1 / 59
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Valbenazine: 1 / 59

Event	System	Groups: affected / at risk
Nausea	Gastrointestinal disorders	Valbenazine: 3 / 59
Somnolence	Nervous system disorders	Valbenazine: 3 / 59

A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Valbenazine

Results posted to the registry

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24

Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24

Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24

secondary measures

Patient Global Impression of Change (PGI-C) Score at Week 24

Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24

Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24

Locally readable linked articles

Overall Study

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Valbenazine

Group	N	Value	Spread / interval
Valbenazine	45	-1.2	-2.98 to 0.58
Valbenazine	45	-2.3	-3.23 to -1.43
Valbenazine	45	-1.6	-2.54 to -0.57

Group	N	Value	Spread / interval
Valbenazine · 1 = Very Much Improved	45	13	-
Valbenazine · 2 = Much Improved	45	19	-
Valbenazine · 3 = Minimally Improved	45	10	-
Valbenazine · 4 = Not Changed	45	2	-
Valbenazine · 5 = Minimal Worse	45	1	-
Valbenazine · 6 = Much Worse	45	0	-
Valbenazine · 7 = Very Much Worse	45	0	-

Milestone	Valbenazine
STARTED	59
Received at Least 1 Dose of Valbenazine	59
COMPLETED	51
NOT COMPLETED	8