CompletedPhase 4

The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

United States89 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 range18 Years – 65 Years

SexALL

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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.
✕. 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.

What they're measuring

Participants With Withdrawal-Emergent Adverse Events

Timeframe: 3 weeks

Trial details

NCT IDNCT03698331

SponsorNeurocrine Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-03

Results submitted2020-05-01

View on ClinicalTrials.gov More Tardive Dyskinesia (TD) trials