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

NCT05110157 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: NBI-98854-ATS3019
• Study Type: interventional
• Target: 442
• Locations: 4 countries
• Sites: 87

Brief 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Valbenazine; Antipsychotic; VMAT2; NBI-98854; Dopamine; Journey; Neurocrine; PANSS; Adjunctive

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10

  Baseline to week 10

Secondary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo once daily.

Drug: Placebo

Vesicular monoamine transporter 2 (VMAT2) inhibitor

EXPERIMENTAL

Valbenazine once daily

Drug: Valbenazine

Interventions

Placebo DRUG

Oral capsules

Placebo

Valbenazine DRUG

Oral capsules

Also known as: NBI-98854

Vesicular monoamine transporter 2 (VMAT2) inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (87)

Neurocrine Clinical Site

Phoenix, Arizona, 85012, United States

Location

Neurocrine Clinical Site

Rogers, Arkansas, 72758, United States

Location

Neurocrine Clinical Site

Anaheim, California, 92805, United States

Location

Neurocrine Clinical Site

Bellflower, California, 90706, United States

Location

Neurocrine Clinical Site

Culver City, California, 90230, United States

Location

Neurocrine Clinical Site

Garden Grove, California, 92845, United States

Location

Neurocrine Clinical Site

Lemon Grove, California, 91945, United States

Location

Neurocrine Clinical Site

Long Beach, California, 90807, United States

Location

Neurocrine Clinical Site

Oceanside, California, 92056, United States

Location

Neurocrine Clinical Site

Pico Rivera, California, 90660, United States

Location

Neurocrine Clinical Site

Riverside, California, 92506, United States

Location

Neurocrine Clinical Site

San Diego, California, 92102, United States

Location

Neurocrine Clinical Site

San Diego, California, 92103, United States

Location

Neurocrine Clinical Site

San Jose, California, 95124, United States

Location

Neurocrine Clinical Site

Santa Ana, California, 92705, United States

Location

Neurocrine Clinical Site

Stanford, California, 94305, United States

Location

Neurocrine Clinical Site

Torrance, California, 90502, United States

Location

Neurocrine Clinical Site

Aventura, Florida, 33180, United States

Location

Neurocrine Clinical Site

Coral Gables, Florida, 33134, United States

Location

Neurocrine Clinical Site

Daytona Beach, Florida, 32114, United States

Location

Neurocrine Clinical Site

Hialeah, Florida, 33012, United States

Location

Neurocrine Clinical Site

Hialeah, Florida, 33013, United States

Location

Neurocrine Clinical Site

Hialeah, Florida, 33016, United States

Location

Neurocrine Clinical Site

Miami, Florida, 33133, United States

Location

Neurocrine Clinical Site

Miami, Florida, 33137, United States

Location

Neurocrine Clinical Site

Miami, Florida, 33144, United States

Location

Neurocrine Clinical Site

Miami Lakes, Florida, 33016, United States

Location

Neurocrine Clinical Site

Okeechobee, Florida, 34972, United States

Location

Neurocrine Clinical Site

Tampa, Florida, 33629, United States

Location

Neurocrine Clinical Site

West Palm Beach, Florida, 33407, United States

Location

Neurocrine Clinical Site

Atlanta, Georgia, 30328, United States

Location

Neurocrine Clinical Site

Evanston, Illinois, 60208, United States

Location

Neurocrine Clinical Site

Springfield, Illinois, 62702, United States

Location

Neurocrine Clinical Site

Grand Rapids, Michigan, 49503, United States

Location

Neurocrine Clinical Site

St Louis, Missouri, 63125, United States

Location

Neurocrine Clinical Site

St Louis, Missouri, 63128, United States

Location

Neurocrine Clinical Site

Lincoln, Nebraska, 68526, United States

Location

Neurocrine Clinical Site

Las Vegas, Nevada, 89102, United States

Location

Neurocrine Clinical Site

Cedarhurst, New York, 11516, United States

Location

Neurocrine Clinical Sites

Glen Oaks, New York, 11004, United States

Location

Neurocrine Clinical Site

New York, New York, 10032, United States

Location

Neurocrine Clinical Site

New York, New York, 10035, United States

Location

Neurocrine Clinical Site

Charlotte, North Carolina, 28211, United States

Location

Neurocrine Clinical Site

Dayton, Ohio, 45417, United States

Location

Neurocrine Clinical Site

Oklahoma City, Oklahoma, 73112, United States

Location

Neurocrine Clinical Site

Austin, Texas, 78754, United States

Location

Neurocrine Clinical Site

Dallas, Texas, 75390, United States

Location

Neurocrine Clinical Site

DeSoto, Texas, 75115, United States

Location

Neurocrine Clinical Site

Houston, Texas, 77081, United States

Location

Neurocrine Clinical Site

Houston, Texas, 77090, United States

Location

Neurocrine Clinical Site

Buenos Aires, 1133, Argentina

Location

Neurocrine Clinical Site

Córdoba, 5004, Argentina

Location

Neurocrine Clinical Site

Kardzhali, 6600, Bulgaria

Location

Neurocrine Clinical Site

Lovech, 5500, Bulgaria

Location

Neurocrine Clinical Site 1

Pleven, 5800, Bulgaria

Location

Neurocrine Clinical Site 2

Pleven, 5800, Bulgaria

Location

Neurocrine Clinical Site 1

Plovdiv, 4000, Bulgaria

Location

Neurocrine Clinical Site 2

Plovdiv, 4000, Bulgaria

Location

Neurocrine Clinical Site

Plovdiv, 4002, Bulgaria

Location

Neurocrine Clinical Site

Plovdiv, 4004, Bulgaria

Location

Neurocrine Clinical Site

Rousse, 7003, Bulgaria

Location

Neurocrine Clinical Site 1

Sofia, 1000, Bulgaria

Location

Neurocrine Clinical Site 2

Sofia, 1000, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1113, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1408, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1510, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1680, Bulgaria

Location

Neurocrine Clinical Site

Veliko Tarnovo, 5000, Bulgaria

Location

Neurocrine Clinical Site

Vratsa, 3000, Bulgaria

Location

Neurocrine Clinical Site 1

Belgrade, 11000, Serbia

Location

Neurocrine Clinical Site 2

Belgrade, 11000, Serbia

Location

Neurocrine Clinical Site 3

Belgrade, 11000, Serbia

Location

Neurocrine Clinical Site 4

Belgrade, 11000, Serbia

Location

Neurocrine Clinical Site 5

Belgrade, 11000, Serbia

Location

Neurocrine Clinical Site 6

Belgrade, 11000, Serbia

Location

Neurocrine Clinical Site

Belgrade, 11108, Serbia

Location

Neurocrine Clinical Site

Gornja Toponica, 18202, Serbia

Location

Neurocrine Clinical Site 1

Kovin, 26220, Serbia

Location

Neurocrine Clinical Site 2

Kovin, 26220, Serbia

Location

Neurocrine Clinical Site 1

Kragujevac, 34000, Serbia

Location

Neurocrine Clinical Site 2

Kragujevac, 34000, Serbia

Location

Neurocrine Clinical Site 3

Kragujevac, 34000, Serbia

Location

Neurocrine Clinical Site

Niš, 18000, Serbia

Location

Neurocrine Clinical Site

Niš, 34000, Serbia

Location

Neurocrine Clinical Site

Novi Kneževac, 23330, Serbia

Location

Neurocrine Clinical Site

Vojvodina, 26300, Serbia

Location

Neurocrine Clinical Site

Vršac, 26300, Serbia

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: November 29, 2021
• Primary Completion: February 4, 2025
• Study Completion: February 18, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2); BU (17); SE (18); US (50)