Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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)
EXCLUSION CRITERIA
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Schizophrenia
Age (in years)
13+
Phase
Phase 3
Participants needed
400
Est. Completion Date
Sep 30, 2025
Treatment type
Interventional
Sponsor
Neurocrine Biosciences
ClinicalTrials.gov identifier
NCT05654870
Study number
NBI-98854-ATS3020
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