Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia

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

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05654870

Enrollment

Registered

2022-12-16

Start date

2023-01-05

Completion date

2023-11-08

Last updated

2024-11-12

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

Conditions

Schizophrenia

Keywords

schizophrenia, valbenazine, antipsychotic, VMAT2, NBI-98854, dopamine, PANSS, Adjunctive

Brief summary

This primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.

Interventions

DRUGValbenazine

Oral treatment

DRUGPlacebo

Placebo matching valbenazine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Medically confirmed diagnosis of schizophrenia * Participant is receiving a stable regimen of background antipsychotic medication * Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay * Participant is an outpatient with stable symptomatology * Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse) Key

Exclusion criteria

* Has a history of treatment resistant schizophrenia * Have a clinically significant unstable medical condition in the judgement of the investigator or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit * Prior (within 6 months of Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors

Design outcomes

Primary

Measure	Time frame
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10	Baseline, Week 10

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026