The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

Completed · Phase 4 · Has a placebo group

Conditions studied: Tardive Dyskinesia (TD)

In brief

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.

Key facts

Study ID

NCT03698331

Run by

Neurocrine Biosciences

People needed

89

Starts

2018-09-14

Expected to finish

2019-04-03

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
• Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
• Are currently pregnant or breastfeeding.
• Have HIV or hepatitis B.

Where it is running

• Neurocrine Clinical Site — Anaheim, California, United States
• Neurocrine Clinical Site — Glendale, California, United States
• Neurocrine Clinical Site — Norwalk, California, United States
• Neurocrine Clinical Site — Oceanside, California, United States
• Neurocrine Clinical Site — San Bernardino, California, United States
• Neurocrine Clinical Site — Hialeah, Florida, United States
• Neurocrine Clinical Site — Hialeah, Florida, United States
• Neurocrine Clinical Site — Hialeah, Florida, United States
• Neurocrine Clinical Site — Honolulu, Hawaii, United States
• Neurocrine Clinical Site — Fort Wayne, Indiana, United States
• Neurocrine Clinical Site — Ann Arbor, Michigan, United States
• Neurocrine Clinical Site — Beechwood, Ohio, United States
• Neurocrine Clinical Site — Oklahoma City, Oklahoma, United States
• Neurocrine Clinical Site — Scranton, Pennsylvania, United States
• Neurocrine Clinical Site — DeSoto, Texas, United States
• Neurocrine Clinical Site — Irving, Texas, United States
• Neurocrine Clinical Site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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