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

April 10, 2024 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

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • 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 Locations

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

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
Intervention / Treatment
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

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

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

Neurocrine Biosciences

Investigators

  • 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)

November 29, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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.

Clinical Trials on Schizophrenia

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe