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

February 2, 2026 updated by: Neurocrine Biosciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
442

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1133
        • Neurocrine Clinical Site
      • Córdoba, Argentina, 5004
        • Neurocrine Clinical Site
  • Bulgaria
      • Kardzhali, Bulgaria, 6600
        • Neurocrine Clinical Site
      • Lovech, Bulgaria, 5500
        • Neurocrine Clinical Site
      • Pleven, Bulgaria, 5800
        • Neurocrine Clinical Site 1
      • Pleven, Bulgaria, 5800
        • Neurocrine Clinical Site 2
      • Plovdiv, Bulgaria, 4004
        • Neurocrine Clinical Site
      • Plovdiv, Bulgaria, 4000
        • Neurocrine Clinical Site 1
      • Plovdiv, Bulgaria, 4000
        • Neurocrine Clinical Site 2
      • Plovdiv, Bulgaria, 4002
        • Neurocrine Clinical Site
      • Rousse, Bulgaria, 7003
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1113
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1408
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1510
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1680
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1000
        • Neurocrine Clinical Site 1
      • Sofia, Bulgaria, 1000
        • Neurocrine Clinical Site 2
      • Veliko Tarnovo, Bulgaria, 5000
        • Neurocrine Clinical Site
      • Vratsa, Bulgaria, 3000
        • Neurocrine Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Neurocrine Clinical Site 1
      • Belgrade, Serbia, 11000
        • Neurocrine Clinical Site 2
      • Belgrade, Serbia, 11000
        • Neurocrine Clinical Site 3
      • Belgrade, Serbia, 11000
        • Neurocrine Clinical Site 4
      • Belgrade, Serbia, 11000
        • Neurocrine Clinical Site 5
      • Belgrade, Serbia, 11000
        • Neurocrine Clinical Site 6
      • Belgrade, Serbia, 11108
        • Neurocrine Clinical Site
      • Gornja Toponica, Serbia, 18202
        • Neurocrine Clinical Site
      • Kovin, Serbia, 26220
        • Neurocrine Clinical Site 1
      • Kovin, Serbia, 26220
        • Neurocrine Clinical Site 2
      • Kragujevac, Serbia, 34000
        • Neurocrine Clinical Site 1
      • Kragujevac, Serbia, 34000
        • Neurocrine Clinical Site 2
      • Kragujevac, Serbia, 34000
        • Neurocrine Clinical Site 3
      • Niš, Serbia, 18000
        • Neurocrine Clinical Site
      • Niš, Serbia, 34000
        • Neurocrine Clinical Site
      • Novi Kneževac, Serbia, 23330
        • Neurocrine Clinical Site
      • Vojvodina, Serbia, 26300
        • Neurocrine Clinical Site
      • Vršac, Serbia, 26300
        • Neurocrine Clinical Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Neurocrine Clinical Site
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Neurocrine Clinical Site
    • California
      • Anaheim, California, United States, 92805
        • Neurocrine Clinical Site
      • Bellflower, California, United States, 90706
        • Neurocrine Clinical Site
      • Culver City, California, United States, 90230
        • Neurocrine Clinical Site
      • Garden Grove, California, United States, 92845
        • Neurocrine Clinical Site
      • Lemon Grove, California, United States, 91945
        • Neurocrine Clinical Site
      • Long Beach, California, United States, 90807
        • Neurocrine Clinical Site
      • Oceanside, California, United States, 92056
        • Neurocrine Clinical Site
      • Pico Rivera, California, United States, 90660
        • Neurocrine Clinical Site
      • Riverside, California, United States, 92506
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92103
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92102
        • Neurocrine Clinical Site
      • San Jose, California, United States, 95124
        • Neurocrine Clinical Site
      • Santa Ana, California, United States, 92705
        • Neurocrine Clinical Site
      • Stanford, California, United States, 94305
        • Neurocrine Clinical Site
      • Torrance, California, United States, 90502
        • Neurocrine Clinical Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Neurocrine Clinical Site
      • Coral Gables, Florida, United States, 33134
        • Neurocrine Clinical Site
      • Daytona Beach, Florida, United States, 32114
        • Neurocrine Clinical Site
      • Hialeah, Florida, United States, 33012
        • Neurocrine Clinical Site
      • Hialeah, Florida, United States, 33013
        • Neurocrine Clinical Site
      • Hialeah, Florida, United States, 33016
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33133
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33137
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33144
        • Neurocrine Clinical Site
      • Miami Lakes, Florida, United States, 33016
        • Neurocrine Clinical Site
      • Okeechobee, Florida, United States, 34972
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33629
        • Neurocrine Clinical Site
      • West Palm Beach, Florida, United States, 33407
        • Neurocrine Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Neurocrine Clinical Site
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Neurocrine Clinical Site
      • Springfield, Illinois, United States, 62702
        • Neurocrine Clinical Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Neurocrine Clinical Site
    • Missouri
      • St Louis, Missouri, United States, 63125
        • Neurocrine Clinical Site
      • St Louis, Missouri, United States, 63128
        • Neurocrine Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Neurocrine Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Neurocrine Clinical Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurocrine Clinical Site
      • Glen Oaks, New York, United States, 11004
        • Neurocrine Clinical Sites
      • New York, New York, United States, 10032
        • Neurocrine Clinical Site
      • New York, New York, United States, 10035
        • Neurocrine Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Neurocrine Clinical Site
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Neurocrine Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Neurocrine Clinical Site
    • Texas
      • Austin, Texas, United States, 78754
        • Neurocrine Clinical Site
      • Dallas, Texas, United States, 75390
        • Neurocrine Clinical Site
      • DeSoto, Texas, United States, 75115
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77081
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77090
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Participants must meet all of the following inclusion criteria:

  1. Completed written informed consent.
  2. At the time of signing the informed consent, participant must be ≥18 years of age
  3. Medically confirmed diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
  4. The initial diagnosis of schizophrenia must be ≥1 year before the screening visit.
  5. Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay.
  6. The participant is treated with a stable regimen antipsychotic medication.

  7. Must meet all of the following criteria at the screening visit 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 the screening visit and Day 1
    • Stable PANSS total score between the screening visit and Day 1
  8. The participant is outpatient with stable symptomatology
  9. The participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse).
  10. Female participants of childbearing potential must agree to use contraception consistently from the screening visit until 30 days after the last dose of study drug or final study visit, whichever is longer.
  11. 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:

    1. 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.
    2. Known hypersensitivity to any component of the formulation of valbenazine.
    3. Has history of treatment resistant schizophrenia.
    4. Evidence of depression as measured by a Calgary Depression Scale for Schizophrenia (CDSS) score ≥11 at the screening visit or Day 1.
    5. Participants with any suicidal behavior or suicidal ideation within 6 months before the screening visit or Day 1.
    6. Diagnosis of moderate or severe substance use disorder within the 6 months before the screening visit.
    7. Have a clinically significant unstable medical condition within 60 days before the screening visit 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.
    8. Prior (within 6 months of the screening visit) or concomitant use of any VMAT2 inhibitor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo once daily.
Drug: Placebo
Oral capsules
Experimental: Vesicular monoamine transporter 2 (VMAT2) inhibitor
Valbenazine once daily
Drug: Valbenazine
Oral capsules
Other Names:
  • NBI-98854

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10
Time Frame: Baseline to week 10
Baseline to week 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 10
Time Frame: Baseline to week 10
Baseline to week 10
Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10
Time Frame: Baseline to week 10
Baseline to week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neurocrine Biosciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NBI-98854-ATS3019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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