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

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

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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