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: 298
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Placebo tablets taken twice daily for 12 weeks. arm 2: SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks. arm 3: SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks. arm 4: SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.

Interventions: intervention 1: SD-809 intervention 2: Placebo
Intervention descriptions: intervention 1: SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food. intervention 2: Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.

Protocol document: