Conditions: Tardive Dyskinesia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 37
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.

Detailed description:

Arms:
arm 1: During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence 1: Placebo once daily dose for Days 1-14 and 12.5 mg NBI-98854 once daily dose for Days 15-28.

Sequence 2: 12.5 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28. arm 2: During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence 3: Placebo once daily dose for Days 1-14 and 50 mg NBI-98854 once daily dose for Days 15-28.

Sequence 4: 50 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.

Interventions: intervention 1: NBI-98854 intervention 2: NBI-98854 intervention 3: Placebo
Intervention descriptions: intervention 1: 12.5 mg powder in bottle once daily for 14 days intervention 2: 50 mg powder in bottle once daily for 14 days intervention 3: Solution containing no active substance

Protocol document: