Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia

Study Overview
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Brief Summary
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The 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.

Detailed Description
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Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine when administered orally once daily as adjunctive treatment in participants with schizophrenia who have had an inadequate response to antipsychotics. The study will enroll approximately 400 participants with a diagnosis of schizophrenia. The expected duration of study participation for each participant is approximately 16 weeks.

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: Placebo
* Drug: Valbenazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Participants must meet all of the following inclusion criteria: Completed written informed consent for adult participants or written and witnessed pediatric assent from the participant and written informed consent from the participant's legal guardian in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and according to local laws and regulations. At the time of signing the informed consent (or assent for pediatric participants), participant must be ≥13 years of age. Medically confirmed diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The initial diagnosis of schizophrenia must be ≥1 year prior to screening. Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay. The participant is treated with a stable regimen antipsychotic medication. Must meet all of the following criteria at screening and Day 1: PANSS total score ≥70 PANSS score of ≥4 on at least 1 of the following: P1 (delusions) P3 (hallucinations) P6 (suspiciousness) G9 (unusual thought content) CGI-S score ≥4 Stable background antipsychotic medication dose between screening and Day 1 Stable PANSS total score between screening and Day 1 The participant is outpatient with stable symptomatology The participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse). Female participants of childbearing potential who have undergone menarche must agree to use contraception consistently from screening until 30 days after the last dose of study drug or final study visit, whichever is longer. Male participants must agree to use contraception consistently from screening until 30 days after last dose of study treatment. Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: Pregnant or breastfeeding or plans to become pregnant during the study. This criterion must be reconfirmed prior to the first dose of study treatment on Day 1. Known hypersensitivity to any component of the formulation of valbenazine. Has history of treatment resistant schizophrenia. Evidence of depression as measured by a Calgary Depression Scale for Schizophrenia (CDSS) score >11 at screening or Day 1. Participants with any suicidal behavior or suicidal ideation within 6 months before screening or Day 1. Diagnosis of moderate or severe substance use disorder within the 6 months prior to screening. Have a clinically significant unstable medical condition within 60 days prior to screening in the judgement of the investigator (30 days prior to screening for minor medical conditions) 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 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo once daily. | Drug: Placebo<br>* Oral capsules<br>|
| Experimental: Vesicular monoamine transporter 2 (VMAT2) inhibitor<br>Valbenazine once daily | Drug: Valbenazine<br>* Oral capsules<br>* Other names: NBI-98854;|

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 to 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 to week 10 | 
| Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10 |  | Baseline to 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, Journey, Neurocrine, PANSS, Adjunctive