Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
NCT ID: NCT05110157
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2021-11-29
2025-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo once daily.
Placebo
Oral capsules
Vesicular monoamine transporter 2 (VMAT2) inhibitor
Valbenazine once daily
Valbenazine
Oral capsules
Interventions
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Placebo
Oral capsules
Valbenazine
Oral capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
Phoenix, Arizona, United States
Neurocrine Clinical Site
Rogers, Arkansas, United States
Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
Bellflower, California, United States
Neurocrine Clinical Site
Culver City, California, United States
Neurocrine Clinical Site
Garden Grove, California, United States
Neurocrine Clinical Site
Lemon Grove, California, United States
Neurocrine Clinical Site
Long Beach, California, United States
Neurocrine Clinical Site
Oceanside, California, United States
Neurocrine Clinical Site
Pico Rivera, California, United States
Neurocrine Clinical Site
Riverside, California, United States
Neurocrine Clinical Site
San Diego, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
Neurocrine Clinical Site
Stanford, California, United States
Neurocrine Clinical Site
Torrance, California, United States
Neurocrine Clinical Site
Aventura, Florida, United States
Neurocrine Clinical Site
Coral Gables, Florida, United States
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Daytona Beach, Florida, United States
Neurocrine Clinical Site
Hialeah, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
Neurocrine Clinical Site
Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
Neurocrine Clinical Site
Miami Lakes, Florida, United States
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Okeechobee, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
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West Palm Beach, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Evanston, Illinois, United States
Neurocrine Clinical Site
Springfield, Illinois, United States
Neurocrine Clinical Site
Grand Rapids, Michigan, United States
Neurocrine Clinical Site
St Louis, Missouri, United States
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St Louis, Missouri, United States
Neurocrine Clinical Site
Lincoln, Nebraska, United States
Neurocrine Clinical Site
Las Vegas, Nevada, United States
Neurocrine Clinical Site
Cedarhurst, New York, United States
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Glen Oaks, New York, United States
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New York, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Buenos Aires, , Argentina
Neurocrine Clinical Site
Córdoba, , Argentina
Neurocrine Clinical Site
Kardzhali, , Bulgaria
Neurocrine Clinical Site
Lovech, , Bulgaria
Neurocrine Clinical Site 1
Pleven, , Bulgaria
Neurocrine Clinical Site 2
Pleven, , Bulgaria
Neurocrine Clinical Site 1
Plovdiv, , Bulgaria
Neurocrine Clinical Site 2
Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
Neurocrine Clinical Site
Rousse, , Bulgaria
Neurocrine Clinical Site 1
Sofia, , Bulgaria
Neurocrine Clinical Site 2
Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
Neurocrine Clinical Site
Veliko Tarnovo, , Bulgaria
Neurocrine Clinical Site
Vratsa, , Bulgaria
Neurocrine Clinical Site 1
Belgrade, , Serbia
Neurocrine Clinical Site 2
Belgrade, , Serbia
Neurocrine Clinical Site 3
Belgrade, , Serbia
Neurocrine Clinical Site 4
Belgrade, , Serbia
Neurocrine Clinical Site 5
Belgrade, , Serbia
Neurocrine Clinical Site 6
Belgrade, , Serbia
Neurocrine Clinical Site
Belgrade, , Serbia
Neurocrine Clinical Site
Gornja Toponica, , Serbia
Neurocrine Clinical Site 1
Kovin, , Serbia
Neurocrine Clinical Site 2
Kovin, , Serbia
Neurocrine Clinical Site 1
Kragujevac, , Serbia
Neurocrine Clinical Site 2
Kragujevac, , Serbia
Neurocrine Clinical Site 3
Kragujevac, , Serbia
Neurocrine Clinical Site
Niš, , Serbia
Neurocrine Clinical Site
Niš, , Serbia
Neurocrine Clinical Site
Novi Kneževac, , Serbia
Neurocrine Clinical Site
Vojvodina, , Serbia
Neurocrine Clinical Site
Vršac, , Serbia
Countries
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Other Identifiers
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NBI-98854-ATS3019
Identifier Type: -
Identifier Source: org_study_id
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