NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group
study to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of
NBI-98854 administered once daily for up to 2 weeks. The study will also allow for an
evaluation of the efficacy of NBI-98854 50 mg once daily for up to 6 weeks and the safety and
tolerability of NBI 98854 50 mg once daily for up to 12 weeks.

The double-blind placebo-controlled treatment period the study has three arms:

- NBI-98854 50 mg once daily for 6 weeks

- NBI-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4
weeks

- placebo

At the end of the 6-week placebo-controlled double-blind treatment period, subjects will
continue in the study for an additional 6-week open-label period where all subjects who have
completed the double-blind treatment period will receive NBI-98854 50 mg once daily. Two and
four weeks after the last dose of study drug, follow-up assessments will be performed.

Inclusion Criteria:

- Have a clinical diagnosis of schizophrenia or schizoaffective disorder and 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.