The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine (NCT03698331) | Clinical Trial Compass
CompletedPhase 4
The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
United States, Puerto Rico89 participantsStarted 2018-09-14
Plain-language summary
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
. Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
. Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
. Be in general good health.
. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
Exclusion criteria
. Have an active, clinically significant unstable medical condition within 1 month before screening.
. Have a known history of substance (drug) dependence, or substance or alcohol abuse.
. Have a significant risk of suicidal or violent behavior.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants With Withdrawal-Emergent Adverse Events
. Have a known history of neuroleptic malignant syndrome.
. Have a known history of long QT syndrome or cardiac arrhythmia.
. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
. Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine clinical study.
. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.