nbi-98854 dose titration study for the treatment of tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of nbi-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of tardive dyskinesia (td) symptoms.

this is a phase 2, randomized, double-blind, placebo-controlled, dose-titration study to evaluate the efficacy, safety, and tolerability of nbi-98854 (titrated to subject's optimal dose in the range of 25 to 75 mg) compared to placebo, administered once daily (q.d.) for a total of 6 weeks of treatment. approximately 90 medically stable male and female subjects with one of the following clinical diagnoses will be enrolled: schizophrenia or schizoaffective disorder with neuroleptic-induced td; mood disorder with neuroleptic-induced td; or gastrointestinal disorder with metoclopramide-induced td. for subjects randomized to active treatment, the starting dose will be 25 mg nbi 98854, which may be escalated in increments of 25 mg every 2 weeks to a maximum of 75 mg to achieve an optimal dose of nbi-98854 for each subject

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.