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

CTIS2022-502233-25-00

Acronym

NBI-98854-ATS3020

Enrollment

199

Registered

2023-06-07

Start date

Unknown

Completion date

2023-11-08

Last updated

2023-09-26

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 Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]

Detailed description

Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10 [Time Frame: Baseline, Week 10], Change in Personal and Social Performance (PSP) Score from Baseline to Week 10 [Time Frame: Baseline, 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 Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]	—

Secondary

Measure	Time frame
Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10 [Time Frame: Baseline, Week 10], Change in Personal and Social Performance (PSP) Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]	—

Countries

Czechia, Germany, Italy, Romania, Slovakia, Spain

Outcome results

None listed

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