NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia

* Have one of the following clinical diagnoses for at least 3 months prior to screening a) schizophrenia or schizoaffective disorder; b) mood disorder; or c) gastrointestinal disorder (e.g., gastroparesis, gastroesophageal reflux disease)

* Have a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening.

* Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.

* Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.

* Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.

* Female subjects must not be pregnant.

* Be in good general health and expected to complete the clinical study as designed.

* Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).

* Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.

* Have a negative alcohol breath test at screening and study start.

* Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.

* Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary).

* Have a known history of neuroleptic malignant syndrome.

* Have a significant risk of suicidal or violent behavior.

* Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine.

* Receiving medication for the treatment of tardive dyskinesia.

* Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.

* 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 an allergy, hypersensitivity, or intolerance to tetrabenazine.

* Have had previous exposure with NBI-98854.