Post-marketing surveillance: Long term efficacy and safety of Valbenazine in patients with tardive dyskinesia

Post-marketing surveillance: Long term efficacy and safety of Valbenazine in patients with tardive dyskinesia - AKARI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049606

Enrollment

500

Registered

2022-12-16

Start date

2023-01-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tardive Dyskinesia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with tardive dyskinesia who receive this drug for the first time -Patients who give written consent to participate in this surveillance

Exclusion criteria

Exclusion criteria: -Patients with a history of hypersensitivity to any in-gredients of this drug -Patients with long QT syndrome congenital or a history of Torsades de pointes [excessive QT interval prolongation, ventricular tachycardia (including Torsades de pointes) may occur.]

Design outcomes

Primary

Measure	Time frame
Safety -Adverse reaction profile -Examination of patient background factors affecting safety -Clinical global impression - severity of underlying disease (CGI-S) -Comparison of safety between doses of this drug Efficacy -Clinical global impression of improvement of tardive dyskinesia (CGI-TD) -Examination of patient background factors affecting efficacy	—

Countries

Japan

Contacts

Public ContactKaoru Ishizaki

Tanabe Pharma Corporation Pharmacovigilance Department

tp-pms-shinchoku.JP@ml.tanabe-pharma.com03-6748-7733

Outcome results