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

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 3
Phase 2

Conditions

Tardive Dyskinesia

Treatments

Drug: Placebo
Drug: MT-5199

Study type

Interventional

Funder types

Industry

Identifiers

NCT03176771
MT-5199-J02

Details and patient eligibility

About

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.

Enrollment

256 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

256 participants in 5 patient groups

MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
Experimental group
Description:
MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks.
Treatment:
Drug: MT-5199
Drug: Placebo
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
Experimental group
Description:
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.
Treatment:
Drug: MT-5199
Drug: Placebo
Placebo (Double-Blind Placebo-Controlled Period)
Experimental group
Description:
Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.
Treatment:
Drug: Placebo
MT-5199 40 mg (Double-Blind Extension Period)
Experimental group
Description:
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.
Treatment:
Drug: MT-5199
Drug: Placebo
MT-5199 80 mg (Double-Blind Extension Period)
Experimental group
Description:
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.
Treatment:
Drug: MT-5199
Drug: Placebo

Trial documents
2

Trial contacts and locations

82

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Data sourced from clinicaltrials.gov

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