Conditions: Tardive Dyskinesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 256
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Detailed description:

Arms:
arm 1: MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks. arm 2: Subjects randomized to the MT-5199 80 mg dose will receive MT-5199 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by MT-5199 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning for 5 weeks. arm 3: Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks. arm 4: At the end of Week 6, subjects will enter a double-blind extension period for 42 weeks. Subjects who were initially randomized to placebo will be re-randomized (1:1) to receive either MT-5199 40 mg or 80 mg and subjects initially randomized to MT-5199 will continue with their current dose. arm 5: At the end of Week 6, subjects will enter a double-blind extension period for 42 weeks. Subjects who were initially randomized to placebo will be re-randomized (1:1) to receive either MT-5199 40 mg or 80 mg and subjects initially randomized to MT-5199 will continue with their current dose. Subjects re-randomized to receive MT-5199 80 mg will receive 40 mg for the first week.

Interventions: intervention 1: MT-5199 intervention 2: Placebo
Intervention descriptions: intervention 1: MT-5199 40 mg capsules intervention 2: MT-5199 placebo capsules

Protocol document:
Prot_000.pdf: 























































































































































































































SAP_001.pdf: