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Valbenazine for Schizophrenia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
SchizophreniaValbenazine - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
UCT-01-097
1
Luvadaxistat
1
Dose Level A

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline, Week 10

Baseline, Week 10
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
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
UCT-01-097
2
Luvadaxistat
2
Dose Level A

Trial Design

2 Treatment Groups

Valbenazine
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

400 Total Participants · 2 Treatment Groups

Primary Treatment: Valbenazine · Has Placebo Group · Phase 3

Valbenazine
Drug
Experimental Group · 1 Intervention: Valbenazine · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valbenazine
2018
Completed Phase 4
~880

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 10

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
70 Previous Clinical Trials
6,394 Total Patients Enrolled
10 Trials studying Schizophrenia
1,652 Patients Enrolled for Schizophrenia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
21 Previous Clinical Trials
2,228 Total Patients Enrolled
3 Trials studying Schizophrenia
921 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have an adult informant (e.g., family member, relative, partner, social worker, caseworker, residential facility staff or nurse).
You have a medically-verified diagnosis of schizophrenia.
You are on a consistent dosage of antipsychotic medication.
A detectable concentration of at least one antipsychotic medication must be present in the participant's plasma.
You are an outpatient with consistent symptoms.
References

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