Conditions: Tardive Dyskinesia
Keywords: Dyskinesias Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 117
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Detailed description:

Arms:
arm 1: SD-809 tablets taken twice daily for 12 weeks. arm 2: Placebo tablets taken twice daily for 12 weeks.

Interventions: intervention 1: SD-809 intervention 2: Placebo
Intervention descriptions: intervention 1: SD-809 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period. intervention 2: Placebo tablets taken twice daily for 12 weeks.

Protocol document: