Clinical trial NCT05110157: Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Valbenazine
Antipsychotic
VMAT2
NBI-98854
Dopamine
Journey
Neurocrine
PANSS
Adjunctive
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10
timeFrame: Baseline to week 10
Secondary outcomes:
measure: Change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 10
timeFrame: Baseline to week 10
measure: Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10
timeFrame: Baseline to week 10
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Neurocrine Clinical Site
state: Arizona
city: Rogers
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Anaheim
country: United States
facility: Neurocrine Clinical Site
state: California
city: Bellflower
country: United States
facility: Neurocrine Clinical Site
state: California
city: Culver City
country: United States
facility: Neurocrine Clinical Site
state: California
city: Garden Grove
country: United States
facility: Neurocrine Clinical Site
state: California
city: Lemon Grove
country: United States
facility: Neurocrine Clinical Site
state: California
city: Long Beach
country: United States
facility: Neurocrine Clinical Site
state: California
city: Oceanside
country: United States
facility: Neurocrine Clinical Site
state: California
city: Pico Rivera
country: United States
facility: Neurocrine Clinical Site
state: California
city: Riverside
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Jose
country: United States
facility: Neurocrine Clinical Site
state: California
city: Santa Ana
country: United States
facility: Neurocrine Clinical Site
state: California
city: Stanford
country: United States
facility: Neurocrine Clinical Site
state: California
city: Torrance
country: United States
facility: Neurocrine Clinical Site
state: California
city: Aventura
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Coral Gables
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Daytona Beach
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami Lakes
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Okeechobee
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Tampa
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: West Palm Beach
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Neurocrine Clinical Site
state: Georgia
city: Evanston
country: United States
facility: Neurocrine Clinical Site
state: Illinois
city: Springfield
country: United States
facility: Neurocrine Clinical Site
state: Illinois
city: Grand Rapids
country: United States
facility: Neurocrine Clinical Site
state: Michigan
city: Saint Louis
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Saint Louis
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Lincoln
country: United States
facility: Neurocrine Clinical Site
state: Nebraska
city: Las Vegas
country: United States
facility: Neurocrine Clinical Site
state: Nevada
city: Cedarhurst
country: United States
facility: Neurocrine Clinical Site
state: New York
city: Glen Oaks
country: United States
facility: Neurocrine Clinical Sites
state: New York
city: New York
country: United States
facility: Neurocrine Clinical Site
state: New York
city: New York
country: United States
facility: Neurocrine Clinical Site
state: New York
city: Charlotte
country: United States
facility: Neurocrine Clinical Site
state: North Carolina
city: Dayton
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Neurocrine Clinical Site
state: Oklahoma
city: Austin
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Dallas
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: DeSoto
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Neurocrine Clinical Site
city: Cordoba
country: Argentina
facility: Neurocrine Clinical Site
city: Kardzhali
country: Bulgaria
facility: Neurocrine Clinical Site
city: Lovech
country: Bulgaria
facility: Neurocrine Clinical Site
city: Pleven
country: Bulgaria
facility: Neurocrine Clinical Site 1
city: Pleven
country: Bulgaria
facility: Neurocrine Clinical Site 2
city: Plovdiv
country: Bulgaria
facility: Neurocrine Clinical Site 1
city: Plovdiv
country: Bulgaria
facility: Neurocrine Clinical Site 2
city: Plovdiv
country: Bulgaria
facility: Neurocrine Clinical Site
city: Plovdiv
country: Bulgaria
facility: Neurocrine Clinical Site
city: Ruse
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site 1
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site 2
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Veliko Tarnovo
country: Bulgaria
facility: Neurocrine Clinical Site
city: Vratsa
country: Bulgaria
facility: Neurocrine Clinical Site
city: Belgrade
country: Serbia
facility: Neurocrine Clinical Site 1
city: Belgrade
country: Serbia
facility: Neurocrine Clinical Site 2
city: Belgrade
country: Serbia
facility: Neurocrine Clinical Site 3
city: Belgrade
country: Serbia
facility: Neurocrine Clinical Site 4
city: Belgrade
country: Serbia
facility: Neurocrine Clinical Site 5
city: Belgrade
country: Serbia
facility: Neurocrine Clinical Site 6
city: Belgrade
country: Serbia
facility: Neurocrine Clinical Site
city: Gornja Toponica
country: Serbia
facility: Neurocrine Clinical Site
city: Kovin
country: Serbia
facility: Neurocrine Clinical Site 1
city: Kovin
country: Serbia
facility: Neurocrine Clinical Site 2
city: Kragujevac
country: Serbia
facility: Neurocrine Clinical Site 1
city: Kragujevac
country: Serbia
facility: Neurocrine Clinical Site 2
city: Kragujevac
country: Serbia
facility: Neurocrine Clinical Site 3
city: Niš
country: Serbia
facility: Neurocrine Clinical Site
city: Niš
country: Serbia
facility: Neurocrine Clinical Site
city: Novi Kneževac
country: Serbia
facility: Neurocrine Clinical Site
city: Vojvodina
country: Serbia
facility: Neurocrine Clinical Site
city: Vršac
country: Serbia
facility: Neurocrine Clinical Site
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: