Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Neurocrine Biosciences
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), 333.82 (see Appendix 17.1) 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 adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
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.
You may not be if
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.
