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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay.
Medically confirmed diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 10
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My antipsychotic medication levels can be measured in my blood.
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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 contraception consistently until 30 days after my last treatment dose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 10
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 Scale (PSP) score from baseline to Week 10
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your condition is severe enough that you are experiencing significant problems in your daily life.My antipsychotic medication dose has not changed recently.You have been diagnosed with schizophrenia that does not respond well to treatment.You experience delusions, which are false beliefs that are not based on reality.You have unusual thoughts that are not typical or expected.My symptoms are stable and I am not hospitalized.You have had thoughts of hurting yourself or have attempted suicide in the past 6 months.My antipsychotic medication levels can be measured in my blood.I was diagnosed with schizophrenia over a year ago.You have a score of 4 or higher on at least one of the following tests called PANSS.My depression score is above 11 on the CDSS scale.You have had a serious problem with drugs or alcohol in the last 6 months.I experience hallucinations.Your PANSS total score should stay the same from the screening to the first day of the trial.I have been diagnosed with schizophrenia.I have not used VMAT2 inhibitors in the last 6 months.I am 13 years old or older.I agree to use birth control from screening until 30 days after my last dose.I am on a consistent dose of antipsychotic medication.I have signed the consent form (or my guardian has, if I'm under age).I agree to use contraception consistently until 30 days after my last treatment dose.Your PANSS total score is 70 or higher.You are allergic to any ingredient in valbenazine.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Vesicular monoamine transporter 2 (VMAT2) inhibitor
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT05110157 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Valbenazine been cleared by the FDA?
"Valbenazine has received a 3 on Power's safety scale. This is due to the fact that this medication is currently in Phase 3 clinical trials, meaning that there are both supportive efficacy data and multiple rounds of safety data available."
Answered by AI
Have other research groups conducted similar investigations before?
"Valbenazine has been under study since 2020. The first trial, sponsored by Neurocrine Biosciences, was conducted that year and involved 150 participants. After the initial success of this Phase 3 drug in 2020, there are now 3 active trials for Valbenazine across 52 cities in 2 countries."
Answered by AI
Are there any Valbenazine-based treatments that have been looked into before?
"Valbenazine was first studied in 2020 at the Neurocrine Clinical Site. Since then, there have been 18300 completed trials with 3 more presently active and recruiting. Many of these latter trials are based out of Garden Grove, California."
Answered by AI
Are there different research facilities conducting this study across the nation?
"There are presently 19 clinical trial sites for this medication, which can be found in Garden Grove, Lemon Grove, Las Vegas and 16 other cities. If you wish to enroll, it would be best to choose the location nearest you to reduce travel time commitments."
Answered by AI
Are new participants being accepted for this research project?
"That is correct. The online clinicaltrials.gov registry confirms that, as of 6/27/2022, this study is still actively recruiting patients. 400 individuals are needed for the trial which has 19 enrolment sites."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
What site did they apply to?
Other
Neurocrine Clinical Site
What questions have other patients asked about this trial?
How long is the screening process and do you have to stay overnight?
PatientReceived no prior treatments
Why did patients apply to this trial?
I love to help others in the community. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 2+ prior treatments
After years of attempting to find the right solution for proper treatment and medication management, it was recommended to me that medical trial therapy maybe the best solution to finding balance in my everyday routine.
PatientReceived 1 prior treatment
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