Trial Outcomes & Findings for Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia (NCT NCT05859698)

Last Updated: 2026-01-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

59 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2026-01-16

Participant Flow

Results are reported for the overall population as a single arm irrespective of dose, as pre-specified in the protocol. Individual participants could receive different dose levels over the duration of the treatment period.

Participant milestones

Participant milestones
Measure	Valbenazine Participants received valbenazine oral capsules once a day (qd) at a dose of either 40 milligrams (mg), 60 mg or 80 mg for up to 24 weeks.
Overall Study STARTED	59
Overall Study Received at Least 1 Dose of Valbenazine	59
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Valbenazine Participants received valbenazine oral capsules once a day (qd) at a dose of either 40 milligrams (mg), 60 mg or 80 mg for up to 24 weeks.
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	2
Overall Study Other Than Specified	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Valbenazine n=59 Participants Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Age, Continuous	61.3 years STANDARD_DEVIATION 11.99 • n=9 Participants
Sex: Female, Male Female	34 Participants n=9 Participants
Sex: Female, Male Male	25 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=9 Participants
Race/Ethnicity, Customized Asian	1 Participants n=9 Participants
Race/Ethnicity, Customized Black or African American	17 Participants n=9 Participants
Race/Ethnicity, Customized White	38 Participants n=9 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race/Ethnicity, Customized Other	2 Participants n=9 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=9 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

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.

Outcome measures

Outcome measures
Measure	Valbenazine n=45 Participants Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24	-8.0 score on a scale Interval -10.48 to -5.44

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Valbenazine n=45 Participants Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24 Item 1: Work/School Impairment	-1.2 score on a scale Interval -2.98 to 0.58
Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24 Item 2: Social Life Impairment	-2.3 score on a scale Interval -3.23 to -1.43
Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24 Item 3: Family Life/Home Responsibilities	-1.6 score on a scale Interval -2.54 to -0.57

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Valbenazine n=45 Participants Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24	13.1 score on a scale Interval 7.7 to 18.48

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Valbenazine n=45 Participants Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Patient Global Impression of Change (PGI-C) Score at Week 24 3 = Minimally Improved	10 Participants
Patient Global Impression of Change (PGI-C) Score at Week 24 4 = Not Changed	2 Participants
Patient Global Impression of Change (PGI-C) Score at Week 24 5 = Minimal Worse	1 Participants
Patient Global Impression of Change (PGI-C) Score at Week 24 6 = Much Worse	0 Participants
Patient Global Impression of Change (PGI-C) Score at Week 24 7 = Very Much Worse	0 Participants
Patient Global Impression of Change (PGI-C) Score at Week 24 1 = Very Much Improved	13 Participants
Patient Global Impression of Change (PGI-C) Score at Week 24 2 = Much Improved	19 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Valbenazine n=45 Participants Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24	-1.47 score on a scale Interval -1.8 to -1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Valbenazine n=45 Participants Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24	-6.8 score on a scale Interval -7.75 to -5.81

Adverse Events

Valbenazine

Serious events: 6 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Valbenazine n=59 participants at risk Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Injury, poisoning and procedural complications Medication error	1.7% 1/59 • Up to 26 weeks The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	1.7% 1/59 • Up to 26 weeks The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Psychiatric disorders Suicidal ideation	1.7% 1/59 • Up to 26 weeks The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Peptic ulcer	1.7% 1/59 • Up to 26 weeks The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
General disorders Chest pain	1.7% 1/59 • Up to 26 weeks The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.7% 1/59 • Up to 26 weeks The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Valbenazine n=59 participants at risk Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks.
Gastrointestinal disorders Nausea	5.1% 3/59 • Up to 26 weeks The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Somnolence	5.1% 3/59 • Up to 26 weeks The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.

Additional Information

Neurocrine Medical Information

Neurocrine Biosciences

Phone: +1 877-641-3461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place