SchizophreniaPhase 3NCT05110157
Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
A Phase 3 study testing Valbenazine in people with Schizophrenia, run by Neurocrine Biosciences at 87 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Valbenazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 87 sitesin 4 countries
- Study dates
- 29 Nov 2021to 18 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria:
- Completed written informed consent.
- At the time of signing the informed consent, participant must be ≥18 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 before the screening visit.
- Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay.
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- The participant is treated with a stable regimen antipsychotic medication.
- 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
- 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 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.
- Male participants must agree to use contraception consistently from screening until 30 days after last dose of study treatment.
Who cannot join
- 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 the screening visit or Day 1.
- Participants with any suicidal behavior or suicidal ideation within 6 months before the screening visit or Day 1.
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- Diagnosis of moderate or severe substance use disorder within the 6 months before the screening visit.
- 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.
- Prior (within 6 months of the screening visit) or concomitant use of any VMAT2 inhibitor.
Trial locations and contacts
87 sites in 4 countries.
87 sites in 4 countries
United States50 sites
Neurocrine Clinical Site
Anaheim, California, 92805
Neurocrine Clinical Site
Atlanta, Georgia, 30328
Neurocrine Clinical Site
Austin, Texas, 78754
Neurocrine Clinical Site
Aventura, Florida, 33180
Neurocrine Clinical Site
Bellflower, California, 90706
Neurocrine Clinical Site
Cedarhurst, New York, 11516
Neurocrine Clinical Site
Charlotte, North Carolina, 28211
Neurocrine Clinical Site
Coral Gables, Florida, 33134
Neurocrine Clinical Site
Culver City, California, 90230
Neurocrine Clinical Site
Dallas, Texas, 75390
Neurocrine Clinical Site
Dayton, Ohio, 45417
Neurocrine Clinical Site
Daytona Beach, Florida, 32114
Neurocrine Clinical Site
DeSoto, Texas, 75115
Neurocrine Clinical Site
Evanston, Illinois, 60208
Neurocrine Clinical Site
Garden Grove, California, 92845
Neurocrine Clinical Sites
Glen Oaks, New York, 11004
Neurocrine Clinical Site
Grand Rapids, Michigan, 49503
Neurocrine Clinical Site
Hialeah, Florida, 33012
Neurocrine Clinical Site
Hialeah, Florida, 33013
Neurocrine Clinical Site
Hialeah, Florida, 33016
Neurocrine Clinical Site
Houston, Texas, 77081
Neurocrine Clinical Site
Houston, Texas, 77090
Neurocrine Clinical Site
Las Vegas, Nevada, 89102
Neurocrine Clinical Site
Lemon Grove, California, 91945
Neurocrine Clinical Site
Lincoln, Nebraska, 68526
Neurocrine Clinical Site
Long Beach, California, 90807
Neurocrine Clinical Site
Miami, Florida, 33133
Neurocrine Clinical Site
Miami, Florida, 33137
Neurocrine Clinical Site
Miami, Florida, 33144
Neurocrine Clinical Site
Miami Lakes, Florida, 33016
Neurocrine Clinical Site
New York, New York, 10032
Neurocrine Clinical Site
New York, New York, 10035
Neurocrine Clinical Site
Oceanside, California, 92056
Neurocrine Clinical Site
Okeechobee, Florida, 34972
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112
Neurocrine Clinical Site
Phoenix, Arizona, 85012
Neurocrine Clinical Site
Pico Rivera, California, 90660
Neurocrine Clinical Site
Riverside, California, 92506
Neurocrine Clinical Site
Rogers, Arkansas, 72758
Neurocrine Clinical Site
San Diego, California, 92102
Neurocrine Clinical Site
San Diego, California, 92103
Neurocrine Clinical Site
San Jose, California, 95124
Neurocrine Clinical Site
Santa Ana, California, 92705
Neurocrine Clinical Site
Springfield, Illinois, 62702
Neurocrine Clinical Site
St Louis, Missouri, 63125
Neurocrine Clinical Site
St Louis, Missouri, 63128
Neurocrine Clinical Site
Stanford, California, 94305
Neurocrine Clinical Site
Tampa, Florida, 33629
Neurocrine Clinical Site
Torrance, California, 90502
Neurocrine Clinical Site
West Palm Beach, Florida, 33407
Serbia18 sites
Neurocrine Clinical Site 1
Belgrade, 11000
Neurocrine Clinical Site 2
Belgrade, 11000
Neurocrine Clinical Site 3
Belgrade, 11000
Neurocrine Clinical Site 4
Belgrade, 11000
Neurocrine Clinical Site 5
Belgrade, 11000
Neurocrine Clinical Site 6
Belgrade, 11000
Neurocrine Clinical Site
Belgrade, 11108
Neurocrine Clinical Site
Gornja Toponica, 18202
Neurocrine Clinical Site 1
Kovin, 26220
Neurocrine Clinical Site 2
Kovin, 26220
Neurocrine Clinical Site 1
Kragujevac, 34000
Neurocrine Clinical Site 2
Kragujevac, 34000
Neurocrine Clinical Site 3
Kragujevac, 34000
Neurocrine Clinical Site
Niš, 18000
Neurocrine Clinical Site
Niš, 34000
Neurocrine Clinical Site
Novi Kneževac, 23330
Neurocrine Clinical Site
Vojvodina, 26300
Neurocrine Clinical Site
Vršac, 26300
Bulgaria17 sites
Neurocrine Clinical Site
Kardzhali, 6600
Neurocrine Clinical Site
Lovech, 5500
Neurocrine Clinical Site 1
Pleven, 5800
Neurocrine Clinical Site 2
Pleven, 5800
Neurocrine Clinical Site 1
Plovdiv, 4000
Neurocrine Clinical Site 2
Plovdiv, 4000
Neurocrine Clinical Site
Plovdiv, 4002
Neurocrine Clinical Site
Plovdiv, 4004
Neurocrine Clinical Site
Rousse, 7003
Neurocrine Clinical Site 1
Sofia, 1000
Neurocrine Clinical Site 2
Sofia, 1000
Neurocrine Clinical Site
Sofia, 1113
Neurocrine Clinical Site
Sofia, 1408
Neurocrine Clinical Site
Sofia, 1510
Neurocrine Clinical Site
Sofia, 1680
Neurocrine Clinical Site
Veliko Tarnovo, 5000
Neurocrine Clinical Site
Vratsa, 3000
Argentina2 sites
Neurocrine Clinical Site
Buenos Aires, 1133
Neurocrine Clinical Site
Córdoba, 5004
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Placebo, Valbenazine
- Keywords
- Schizophrenia, Valbenazine, Antipsychotic, VMAT2, NBI-98854, Dopamine, Journey, Neurocrine, PANSS, Adjunctive
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral capsules
ValbenazineDrug
Also called NBI-98854
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo once daily. Receives: Drug: Placebo |
| Vesicular monoamine transporter 2 (VMAT2) inhibitor | Experimental | Valbenazine once daily Receives: Drug: Valbenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10
Measured: Baseline to week 10
Secondary outcomes (2)
Change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 10
Measured: Baseline to week 10
Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10
Measured: Baseline to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start29 Nov 2021
- Primary completion4 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110157
- Sponsor's protocol ID
- NBI-98854-ATS3019
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05110157
- Acronym / sponsor ID
- NBI-98854-ATS3019
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Valbenazine, Antipsychotic, VMAT2, NBI-98854, Dopamine, Journey, Neurocrine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily. |
| Vesicular monoamine transporter 2 (VMAT2) inhibitor | Experimental | Drug: ValbenazineValbenazine once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants must meet all of the following inclusion criteria:
- Completed written informed consent.
- At the time of signing the informed consent, participant must be ≥18 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 before the screening visit.
Key exclusion criteria (9 listed)
- Participants will be excluded from the study if they meet any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral capsules | Drug | Placebo |
| ValbenazineAlso: NBI-98854Oral capsules | Drug | Vesicular monoamine transporter 2 (VMAT2) inhibitor |
Primary outcome
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10
Time frame: Baseline to week 10
2 secondary outcomes
Change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 10
Time frame: Baseline to week 10
Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10
Time frame: Baseline to week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Lead study director
Neurocrine Biosciences
87 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valbenazine in people with Schizophrenia, run by Neurocrine Biosciences at 87 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Serbia, Bulgaria, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10 (time frame: Baseline to week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.