Back to resultsStudy to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valbenazine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, valbenazine, antipsychotic, VMAT2, NBI-98854, dopamine, PANSS, Adjunctive
Eligibility Criteria
Key Inclusion Criteria: Medically confirmed diagnosis of schizophrenia Participant is receiving a stable regimen of background antipsychotic medication Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay Participant is an outpatient with stable symptomatology Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse) Key Exclusion Criteria: Has a history of treatment resistant schizophrenia Have a clinically significant unstable medical condition 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 Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors
Sites / Locations
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
- Neurocrine Clinical SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Valbenazine
Placebo
Arm Description
Valbenazine once daily
Placebo once daily
Outcomes
Primary Outcome Measures
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10
Secondary Outcome Measures
Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10
Change in Personal and Social Performance (PSP) Score from Baseline to Week 10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05654870
Brief Title
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an 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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, valbenazine, antipsychotic, VMAT2, NBI-98854, dopamine, PANSS, Adjunctive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Valbenazine
Arm Type
Experimental
Arm Description
Valbenazine once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
Valbenazine
Other Intervention Name(s)
NBI-98854
Intervention Description
Oral treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching valbenazine
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10
Time Frame
Baseline, Week 10
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10
Time Frame
Baseline, Week 10
Title
Change in Personal and Social Performance (PSP) Score from Baseline to Week 10
Time Frame
Baseline, Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Medically confirmed diagnosis of schizophrenia
Participant is receiving a stable regimen of background antipsychotic medication
Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay
Participant is an outpatient with stable symptomatology
Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse)
Key Exclusion Criteria:
Has a history of treatment resistant schizophrenia
Have a clinically significant unstable medical condition 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 Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neurocrine Medical Information Call Center
Phone
877-641-3461
Email
medinfo@neurocrine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Lead
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34134
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33629
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Fairlawn
State/Province
Ohio
ZIP/Postal Code
44333
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://journeyresearchstudies.com/
Description
Study Website - Journey Study
Learn more about this trial
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
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