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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
Medically confirmed diagnosis of schizophrenia
Participant is receiving a stable regimen of background antipsychotic medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 10
Awards & highlights

Study Summary

This trial will study how a new medication affects schizophrenia symptoms that don't respond to existing treatments.

Who is the study for?
This trial is for adults with schizophrenia who aren't responding well to their current antipsychotic medication. They must have a stable regimen of this medication, detectable plasma levels, and be outpatients with steady symptoms. An adult informant must be involved in their care. Those with treatment-resistant schizophrenia or unstable medical conditions are excluded.Check my eligibility
What is being tested?
The study tests if Valbenazine added to existing antipsychotic treatment helps reduce schizophrenia symptoms better than a placebo (a substance with no active drug). Participants will randomly receive either Valbenazine or the placebo alongside their regular medication.See study design
What are the potential side effects?
Valbenazine may cause side effects like sleepiness, balance problems, dry mouth, and restlessness. It might also lead to gastrointestinal issues such as nausea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia by a doctor.
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I am on a steady dose of medication for psychosis.
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My antipsychotic medication levels can be measured by a test.
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My health condition is stable and I am not hospitalized.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ValbenazineExperimental 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
6,351 Total Patients Enrolled
11 Trials studying Schizophrenia
1,553 Patients Enrolled for Schizophrenia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,177 Total Patients Enrolled
4 Trials studying Schizophrenia
873 Patients Enrolled for Schizophrenia

Media Library

Valbenazine Clinical Trial Eligibility Overview. Trial Name: NCT05654870 — Phase 3
Schizophrenia Research Study Groups: Placebo, Valbenazine
Schizophrenia Clinical Trial 2023: Valbenazine Highlights & Side Effects. Trial Name: NCT05654870 — Phase 3
Valbenazine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05654870 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have any slots open for participants?

"According to its entry on clinicaltrials.gov, this trial is currently recruiting participants and has been edited as recently as January 20th, 2021. It was initially posted on the 1st of January in 20203"

Answered by AI

Has the Valbenazine drug been given authorization by the FDA?

"We are confident in valbenazine's safety, earning it a score of 3 on our scale. This is due to the extensive research and clinical trials that demonstrate its efficacy and multiple rounds of evidence supporting its safety."

Answered by AI

How many participants are enrolling in this research project?

"Affirmative. The online records hosted on clinicaltrials.gov demonstrate that this experiment is currently open for enrolment and was first posted on January 1st 2023, with the last revision being made in January 20th of the same year. 400 individuals are needed from 3 various medical centres to participate in the trial."

Answered by AI

Who else is applying?

What site did they apply to?
Neurocrine Clinical Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I've tried everything to get rid of these voices please help.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Neurocrine Clinical Site: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
2023. "Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05654870.
~206 spots leftby Sep 2025
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