Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
- Registration Number
- NCT05654870
- Lead Sponsor
- Neurocrine Biosciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo once daily Valbenazine Valbenazine Valbenazine once daily
- Primary Outcome Measures
Name Time Method Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 Baseline, Week 10
- Secondary Outcome Measures
Name Time Method Change in Personal and Social Performance (PSP) Score from Baseline to Week 10 Baseline, Week 10 Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10 Baseline, Week 10
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of valbenazine in modulating vesicular monoamine transporter 2 (VMAT2) for schizophrenia treatment?
How does valbenazine compare to other adjunctive antipsychotics like aripiprazole or cariprazine in treatment-resistant schizophrenia populations?
Which biomarkers could predict response to valbenazine as an adjunctive therapy in schizophrenia patients with inadequate antipsychotic response?
What are the most common adverse events associated with valbenazine in phase 3 trials for schizophrenia and how are they managed?
How does valbenazine's mechanism differ from first-generation and second-generation antipsychotics in managing schizophrenia symptoms?
Trial Locations
- Locations (1)
Neurocrine Clinical Site
🇺🇸Atlanta, Georgia, United States
Neurocrine Clinical Site🇺🇸Atlanta, Georgia, United States