A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to placebo, administered once daily. The study design includes a double-blind, placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments will be conducted 4 weeks after the last dose of the study drug.

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 good general health.
• Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
• Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, 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, or 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 of screening (some exceptions allowed)
• Have received an investigational drug within 30 days prior to 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.
• Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
• Are currently pregnant or breastfeeding.