Phase 3
Completed N=256
Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
Source: ClinicalTrials.gov NCT03176771 ↗Enrolled (actual)
256
Serious AEs
7.9%
Results posted
Aug 2023
Primary outcomePrimary: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 — -0.1; -2.3; -3.7 units on a scale — p=<0.001
◆ Published Evidence
Emerging
13citations · ~3 / year
Efficacy and safety of valbenazine in Japanese patients with tardive dyskinesia: A multicenter, randomized, double-blind, placebo-controlled study (J-KINECT).
Summary
The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Linked Publications (3)
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Efficacy and safety of valbenazine in Japanese patients with tardive dyskinesia: A multicenter, randomized, double-blind, placebo-controlled study (J-KINECT).
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Efficacy and Safety of Valbenazine in Elderly and Nonelderly Japanese Patients With Tardive Dyskinesia: A Post Hoc Analysis of the J-KINECT Study.
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Efficacy and Safety of Valbenazine in Japanese Patients With Tardive Dyskinesia and Schizophrenia/Schizoaffective Disorder or Bipolar Disorder/Depressive Disorder: Primary Results and Post Hoc Analyses of the J-KINECT Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 |
-0.1; -2.3; -3.7 | <0.001 sig |
| SECONDARY Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder) |
10.3; 23.9; 47.2 | 0.027 sig |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6 |
-2.3; -3.8; -4.7 | 0.013 sig |
| SECONDARY Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6 |
3.4; 3.0; 2.8 | 0.021 sig |
Eligibility Criteria
Inclusion Criteria
- Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, Bipolar Disorder, or Depressive Disorders.
- Have a clinical diagnosis of neuroleptic-induced TD.
- Have moderate or severe TD.
- If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or bipolar disorder, or depressive disorders, be on stable doses.
Exclusion Criteria
- Have an active, clinically significant unstable medical condition in screening period.
- Have a significant risk of suicidal or violent behavior.
- Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
- Are currently pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT03176771) and the linked publication. 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. Informational only — not medical advice.