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

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Brief Title

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

Official Title

A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Fixed-Dose Study to Evaluate the Efficacy and Safety of MT-5199 for the Treatment in Patients With Tardive Dyskinesia (J-KINECT)

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.
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Severity of tardive dyskinesia (TD) symptoms assessed by Abnormal Involuntary Movements Scale (AIMS), change from baseline


Condition

Tardive Dyskinesia

Intervention

MT-5199

Study Arms / Comparison Groups

 MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
Description:  MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

256

Start Date

June 21, 2017

Completion Date

September 29, 2020

Primary Completion Date

September 29, 2020

Eligibility 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.
      

Gender

All

Ages

20 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

General Manager, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT03176771

Organization ID

MT-5199-J02


Responsible Party

Sponsor

Study Sponsor

Mitsubishi Tanabe Pharma Corporation


Study Sponsor

General Manager, Study Director, Mitsubishi Tanabe Pharma Corporation


Verification Date

July 2020