Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

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.
• Female subjects must not be pregnant.
• Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
• Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
• Have moderate or severe TD
• If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
• Be in general good health.
• Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
• Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.

Exclusion criteria

• Have an active, clinically significant unstable medical condition within 1 month prior to screening.
• Have a known history of substance dependence, substance (drug) 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 tachy-arrhythmia.
• Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
• 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 tetrabenazine.
• Are currently pregnant or breastfeeding.