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NCT05110157 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05110157
Other study ID # NBI-98854-ATS3019
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 29, 2021
Est. completion date September 2024

Study information
Verified date June 2024
Source Neurocrine Biosciences
Contact Neurocrine Medical Information Call Center
Phone 877-641-3461
Email medinfo@neurocrine.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Oral capsules
• Valbenazine
Oral capsules

Locations
Country Name City State
Bulgaria 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 Plovdiv
Bulgaria Neurocrine Clinical Site Plovdiv
Bulgaria Neurocrine Clinical Site 1 Plovdiv
Bulgaria Neurocrine Clinical Site 2 Plovdiv
Bulgaria Neurocrine Clinical Site Ruse
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site 1 Sofia
Bulgaria Neurocrine Clinical Site 2 Sofia
Bulgaria Neurocrine Clinical Site Veliko Tarnovo
Bulgaria Neurocrine Clinical Site Vratsa
Serbia Neurocrine Clinical Site Belgrade
Serbia 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 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
United States Neurocrine Clinical Site Anaheim California
United States Neurocrine Clinical Site Atlanta Georgia
United States Neurocrine Clinical Site Austin Texas
United States Neurocrine Clinical Site Aventura Florida
United States Neurocrine Clinical Site Bellflower California
United States Neurocrine Clinical Site Cedarhurst New York
United States Neurocrine Clinical Site Coral Gables Florida
United States Neurocrine Clinical Site Culver City California
United States Neurocrine Clinical Site Dayton Ohio
United States Neurocrine Clinical Site Daytona Beach Florida
United States Neurocrine Clinical Site DeSoto Texas
United States Neurocrine Clinical Site Evanston Illinois
United States Neurocrine Clinical Site Garden Grove California
United States Neurocrine Clinical Sites Glen Oaks New York
United States Neurocrine Clinical Site Grand Rapids Michigan
United States Neurocrine Clinical Site Hialeah Florida
United States Neurocrine Clinical Site Hialeah Florida
United States Neurocrine Clinical Site Hialeah Florida
United States Neurocrine Clinical Site Houston Texas
United States Neurocrine Clinical Site Houston Texas
United States Neurocrine Clinical Site Las Vegas Nevada
United States Neurocrine Clinical Site Lemon Grove California
United States Neurocrine Clinical Site Lincoln Nebraska
United States Neurocrine Clinical Site Long Beach California
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Lakes Florida
United States Neurocrine Clinical Site New York New York
United States Neurocrine Clinical Site New York New York
United States Neurocrine Clinical Site Oceanside California
United States Neurocrine Clinical Site Okeechobee Florida
United States Neurocrine Clinical Site Oklahoma City Oklahoma
United States Neurocrine Clinical Site Phoenix Arizona
United States Neurocrine Clinical Site Pico Rivera California
United States Neurocrine Clinical Site Riverside California
United States Neurocrine Clinical Site Rogers Arkansas
United States Neurocrine Clinical Site Saint Louis Missouri
United States Neurocrine Clinical Site Saint Louis Missouri
United States Neurocrine Clinical Site San Diego California
United States Neurocrine Clinical Site San Diego California
United States Neurocrine Clinical Site San Jose California
United States Neurocrine Clinical Site Santa Ana California
United States Neurocrine Clinical Site Springfield Illinois
United States Neurocrine Clinical Site Stanford California
United States Neurocrine Clinical Site Tampa Florida
United States Neurocrine Clinical Site Torrance California
United States Neurocrine Clinical Site West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Bulgaria,  Serbia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10 Baseline to week 10
Secondary Change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 10 Baseline to week 10
Secondary Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10 Baseline to week 10
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