442 Participants Needed

Valbenazine for Schizophrenia

Recruiting at 77 trial locations
NM
Overseen ByNeurocrine Medical Information Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Neurocrine Biosciences
Must be taking: Antipsychotics
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The 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.

Do I have to stop taking my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. In fact, you must be on a stable regimen of antipsychotic medication to participate.

What data supports the idea that Valbenazine for Schizophrenia is an effective drug?

The available research does not provide specific data supporting the effectiveness of Valbenazine for treating schizophrenia. The studies mentioned focus on other drugs or placebo effects in schizophrenia treatment, but do not include Valbenazine. Therefore, there is no direct evidence from the provided information to support Valbenazine's effectiveness for schizophrenia.12345

What safety data exists for Valbenazine in treating schizophrenia?

The provided research does not contain specific safety data for Valbenazine or its other names (Ingrezza, Ingrezza Sprinkle, DYSVAL, MT 5199, NBI-98854, REMLEAS, Valbenazine-tosylate) in the treatment of schizophrenia. The studies focus on other antipsychotic drugs and their safety profiles, but Valbenazine is not mentioned. Further research specifically targeting Valbenazine would be needed to answer this question.678910

Is Valbenazine a promising drug for treating schizophrenia?

Valbenazine shows promise as a drug for treating schizophrenia because antipsychotic drugs generally help prevent relapses and reduce symptoms better than a placebo.1281112

Research Team

CD

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Eligibility Criteria

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.

Inclusion Criteria

The participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse).
My antipsychotic medication dose has not changed recently.
My symptoms are stable and I am not hospitalized.
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Exclusion Criteria

You have been diagnosed with schizophrenia that does not respond well to treatment.
Pregnant or breastfeeding or plans to become pregnant during the study. This criterion must be reconfirmed prior to the first dose of study treatment on Day 1.
You have had thoughts of hurting yourself or have attempted suicide in the past 6 months.
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Treatment Details

Interventions

  • Placebo
  • Valbenazine
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials
78
Recruited
6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD

Findings from Research

In a pooled analysis of two 6-week trials involving 422 patients with schizophrenia, early response to antipsychotic treatment (low-dose olanzapine or haloperidol) significantly distinguished active drug from placebo, with a greater mean reduction in psychiatric symptoms observed at 2 weeks.
The study suggests that shortening the duration of placebo-controlled trials from 6 weeks to 2-4 weeks is feasible for identifying efficacy in acutely ill patients, as early treatment response was predictive of overall treatment success.
Early onset of antipsychotic action in schizophrenia: evaluating the possibility of shorter acute efficacy trials.Kinon, BJ., Chen, L., Stauffer, VL., et al.[2021]
In a study of 672 patients with schizophrenia, early improvement in symptoms (measured by a 10% reduction in PANSS score at week 1) was strongly predictive of a subsequent placebo response by week 6.
Lower baseline scores for disorganized thoughts also correlated with a higher likelihood of responding to placebo, suggesting that these factors can help identify potential placebo responders early in clinical trials.
Placebo effects in adult and adolescent patients with schizophrenia: combined analysis of nine RCTs.Kubo, K., Fleischhacker, WW., Suzuki, T., et al.[2020]
In a study of 450 patients with schizophrenia receiving placebo injections, a 10%-15% reduction in the PANSS total score after the first week was found to be a strong predictor of long-term response at week 9, indicating that early improvements can help identify potential placebo responders.
Patients with better judgment and insight at baseline (lower PANSS G12 scores) were also more likely to show a placebo response, suggesting that certain demographic and clinical characteristics may influence the effectiveness of placebo treatments in clinical trials.
Early Placebo Improvement Is a Marker for Subsequent Placebo Response in Long-Acting Injectable Antipsychotic Trials for Schizophrenia: Combined Analysis of 4 RCTs.Kumagai, F., Suzuki, T., Fleischhacker, WW., et al.[2019]

References

Early onset of antipsychotic action in schizophrenia: evaluating the possibility of shorter acute efficacy trials. [2021]
Placebo effects in adult and adolescent patients with schizophrenia: combined analysis of nine RCTs. [2020]
Early Placebo Improvement Is a Marker for Subsequent Placebo Response in Long-Acting Injectable Antipsychotic Trials for Schizophrenia: Combined Analysis of 4 RCTs. [2019]
Deprenyl augmentation for treating negative symptoms of schizophrenia: a double-blind, controlled study. [2019]
Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. [2015]
Adverse effects associated with second-generation antipsychotic long-acting injection treatment: a comprehensive systematic review. [2018]
Safety and efficacy of long-acting injectable risperidone in daily practice: an open-label, noninterventional, prospective study in schizophrenia and related disorders. [2019]
Antipsychotic drugs versus placebo for relapse prevention in schizophrenia: a systematic review and meta-analysis. [2022]
The risk of death among adult participants in trials of antipsychotic drugs in schizophrenia. [2010]
Upcoming agents for the treatment of schizophrenia: mechanism of action, efficacy and tolerability. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Predictors of Placebo Response in Pharmacological Clinical Trials of Negative Symptoms in Schizophrenia: A Meta-regression Analysis. [2022]
60 years of placebo-controlled antipsychotic drug trials in acute schizophrenia: Meta-regression of predictors of placebo response. [2019]