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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Valbenazine for Tardive Dyskinesia
Verified Trial
Phase 4
Recruiting
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
Have a clinical diagnosis of neuroleptic-induced TD
Must not have
Are you a significant risk for suicidal or violent behavior?
Do you have a diagnosis of moderate or severe substance use disorder within the last 6 months?
Timeline
Screening 3 days
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
Study Summary
This trial will test how Valbenazine affects TD patients' quality of life, ability to function, and response to treatment.
Who is the study for?
This trial is for adults with tardive dyskinesia, a movement disorder often related to long-term use of certain psychiatric medications. Participants must be stable outpatients with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder and on a steady medication regimen. Those with more prominent involuntary movements not due to TD or significant unstable medical conditions are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of valbenazine over a period of up to 24 weeks. It focuses on how well valbenazine improves the quality of life, functioning, and perceived treatment effect in patients as reported by both themselves and their clinicians.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, common side effects of valbenazine may include sleepiness, balance issues (risk of falls), restlessness (akathisia), dry mouth, and blurred vision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder.
Select...
I have been diagnosed with TD due to antipsychotic medication.
Select...
I have been on a stable dose of medication for my mental health condition for the last 30 days.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with TD due to neuroleptics for over three months.
Select...
I have been diagnosed with Schizophrenia, Schizoaffective, Bipolar Disorder, or MDD.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in the EQ-visual analogue scale (EQ-VAS) score at Week 24
Change from baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 at Week 24
Change from baseline in the Tardive Dyskinesia Impact Scale (TDIS) total score at Week 24
Secondary outcome measures
Change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at Week 24
Change from baseline in the Clinical Global Impression of Severity - TD (CGI-TD-S) score at Week 24
Patient Global Impression of Change (PGI-C) score at Week 24
Trial Design
1Treatment groups
Experimental Treatment
Group I: ValbenazineExperimental Treatment1 Intervention
Valbenazine administered once daily for 24 weeks.
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
6,691 Total Patients Enrolled
12 Trials studying Tardive Dyskinesia
1,154 Patients Enrolled for Tardive Dyskinesia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,517 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with TD due to antipsychotic medication.I have been diagnosed with TD due to neuroleptics for over three months.I have involuntary movements more noticeable than my tardive dyskinesia.I have been on a stable dose of medication for my mental health condition for the last 30 days.I have been diagnosed with Schizophrenia, Schizoaffective, Bipolar Disorder, or MDD.You have a medical condition that is not stable or under control, or your lab test results are abnormal and concerning according to the doctor.I am 18 years old or older.I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Valbenazine
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Valbenazine been granted regulatory endorsement by the FDA?
"The safety of Valbenazine is rated 3 out of 3 since this Phase 4 trial has been approved."
Answered by AI
How many participants have joined the research project?
"Affirmative. Clinicaltrials.gov confirms that this research initiative, initially posted on May 25th 2023, is actively enrolling patients. The trial seeks to recruit 60 people from two distinct medical centres."
Answered by AI
Is there currently an open enrollment period for this investigation?
"Affirmative, clinicaltrials.gov records that a search for prospective candidates is currently in progress. This trial was initially advertised on May 25th 2023 and edited lastly on June 8th 2023, requiring 60 participants to be enrolled from two locations."
Answered by AI
Who else is applying?
What site did they apply to?
Other
Neurocrine Clinical Site
SanRo Clinical Research Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I'm tired of being a guinea pig and hearing try this try that I've been on more then 5 anti depression drugs and i have not yet found 1 that works with me for me and not against me.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- SanRo Clinical Research Group: < 24 hours
Average response time
- < 2 Days
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