Adults 18 to 85, any sex, with Tardive Dyskinesia (TD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16Primary· Week 8, Week 16
The AIMS rates 10 items of involuntary movement, each item ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Items assess facial, oral, extremity, and trunk movements, as well as self-awareness of abnormal movements. The AIMS Dyskinesia Total Score is the sum of items 1-7 and ranges from 0 to 28, with higher scores indicating more severe dyskinesia. Least-squares mean were estimated using a mixed-effects model for repeated measures.
Group
Value
95% CI
Placebo-controlled Placebo
0.6
-0.8 – 1.9
Placebo-controlled Valbenazine
-1.6
-3.0 – -0.3
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Health State Index Score at Week 16Secondary· Baseline, Week 16
The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The health state index score is based on the results of the individual health profiles using the United States value set and ranges from -0.573 to 1.0, with higher scores indicating higher health utility.
Group
Value
95% CI
Placebo-controlled Placebo
0.09
± 0.03
Placebo-controlled Valbenazine
0.16
± 0.03
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Week 16Secondary· Baseline, Week 16
The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 ("the worst imaginable health") to 100 ("the best imaginable health").
Group
Value
95% CI
Placebo-controlled Placebo
4.5
± 2.5
Placebo-controlled Valbenazine
6.5
± 2.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Open-label valbenazine group: from baseline up to randomization (Week 8). Placebo-controlled placebo and valbenazine groups: from randomization (Week 8) up to Week 20.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT05053321 — Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
· Phase 1
· withdrawn
NCT05859698 — Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyski
· Phase 4
· completed
NCT05654870 — Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
· Phase 3
· terminated
NCT05110157 — Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
· Phase 3
· completed
NCT04102579 — Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
· Phase 3
· completed
Other recruiting trials for Tardive Dyskinesia (TD)
Currently open trials in the same condition.
NCT06731868 — Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
· Phase 1, PHASE2
· recruiting
Other Neurocrine Biosciences trials
Trials by the same sponsor.
NCT07187375 — Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Le
· Phase 2
· recruiting
NCT06267846 — A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
· Phase 2
· completed
NCT05859698 — Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyski
· Phase 4
· completed
NCT05654870 — Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
· Phase 3
· terminated
NCT05493293 — Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Neurocrine Biosciences
Last refreshed: 20 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03891862.