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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Valbenazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valbenazine<br>Valbenazine once daily | Drug: Valbenazine<br>* Oral treatment<br>* Other names: NBI-98854;|
| Placebo Comparator: Placebo<br>Placebo once daily | Drug: Placebo<br>* Placebo matching valbenazine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 |  | Baseline, Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, valbenazine, antipsychotic, VMAT2, NBI-98854, dopamine, PANSS, Adjunctive