Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia

• Status: Completed
• Trial end date: 2020-09-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

Inclusion Criteria:

• Have one of the following clinical diagnoses for at least 3 months prior to screening:

Schizophrenia or Schizoaffective Disorder, Bipolar Disorder, or Depressive Disorders.

• Have a clinical diagnosis of neuroleptic-induced TD.

• Have moderate or severe TD.

• If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or bipolar disorder, or depressive disorders, be on stable doses.

Exclusion Criteria:

• Have an active, clinically significant unstable medical condition in screening period.

• Have a significant risk of suicidal or violent behavior.

• Have a known history of long QT syndrome or cardiac tachy-arrhythmia.

• Are currently pregnant or breastfeeding.