A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508433-14-00

Acronym

NBI-98854-ATS3019

Enrollment

192

Registered

2024-03-07

Start date

2022-09-30

Completion date

2025-02-11

Last updated

2024-10-14

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

Conditions

Schizophrenia

Brief summary

Change in PANSS total score from baseline to Week 10.

Detailed description

Change in CGI-S score from baseline to Week 10, Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10

Interventions

DRUGValbenazine

DRUGPlacebo for valbenazine capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in PANSS total score from baseline to Week 10.	—

Secondary

Measure	Time frame
Change in CGI-S score from baseline to Week 10, Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10	—

Countries

Bulgaria, Croatia, Czechia, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026