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Valbenazine for Schizophrenia

Phase 3
Recruiting
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse).
Stable background antipsychotic medication dose between screening and Day 1
Must not have
You have been diagnosed with HIV (Human Immunodeficiency Virus)
Timeline
Screening 3 weeks
Treatment 10 weeks
Follow Up baseline to week 10
Awards & highlights
Pivotal Trial

Summary

This trial will evaluate whether valbenazine can improve symptoms of schizophrenia in patients who haven't responded well to antipsychotic treatment.

Who is the study for?
This trial is for individuals aged 13 or older with a medically confirmed diagnosis of schizophrenia for at least one year. They must be on stable antipsychotic medication and not responding adequately to treatment. Participants need an adult informant and agree to use contraception. Excluded are those pregnant, breastfeeding, resistant to treatments, recently suicidal, or with severe substance disorders.
What is being tested?
The Journey Study tests Valbenazine as an additional treatment against a placebo in people with schizophrenia who aren't fully helped by their current antipsychotics. The goal is to see if Valbenazine can better alleviate symptoms when used alongside standard medications.
What are the potential side effects?
While the study doesn't list specific side effects for Valbenazine in this context, common ones may include sleepiness, balance problems (like dizziness), nausea, dry mouth, restlessness and blurred vision based on its known profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My antipsychotic medication dose has not changed recently.
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My symptoms are stable and I am not hospitalized.
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I was diagnosed with schizophrenia over a year ago.
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I have been diagnosed with schizophrenia.
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I am 13 years old or older.
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I agree to use birth control from screening until 30 days after my last dose.
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I am on a consistent dose of antipsychotic medication.
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I agree to use contraception consistently until 30 days after my last treatment dose.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ 10 weeks
Follow Up ~baseline to week 10
This trial's timeline: 3 weeks for screening, 10 weeks for treatment, and baseline to week 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10
Secondary study objectives
Change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 10
Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vesicular monoamine transporter 2 (VMAT2) inhibitorExperimental Treatment1 Intervention
Valbenazine once daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valbenazine
2018
Completed Phase 4
~880

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,321 Total Patients Enrolled
11 Trials studying Schizophrenia
1,550 Patients Enrolled for Schizophrenia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,174 Total Patients Enrolled
4 Trials studying Schizophrenia
870 Patients Enrolled for Schizophrenia

Media Library

Valbenazine Clinical Trial Eligibility Overview. Trial Name: NCT05110157 — Phase 3
Schizophrenia Research Study Groups: Placebo, Vesicular monoamine transporter 2 (VMAT2) inhibitor
Schizophrenia Clinical Trial 2023: Valbenazine Highlights & Side Effects. Trial Name: NCT05110157 — Phase 3
Valbenazine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05110157 — Phase 3
Schizophrenia Patient Testimony for trial: Trial Name: NCT05110157 — Phase 3
~102 spots leftby Nov 2025
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