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Trial record 2 of 72 for:    Tardive Dyskinesia

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

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ClinicalTrials.gov Identifier: NCT03176771
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: MT-5199 Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks.
Drug: MT-5199
MT-5199 40 mg capsules

Drug: Placebo
MT-5199 placebo capsules

Experimental: MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
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.
Drug: MT-5199
MT-5199 40 mg capsules

Drug: Placebo
MT-5199 placebo capsules

Experimental: Placebo (Double-Blind Placebo-Controlled Period)
Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.
Drug: Placebo
MT-5199 placebo capsules

Experimental: MT-5199 40 mg (Double-Blind Extension Period)
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.
Drug: MT-5199
MT-5199 40 mg capsules

Drug: Placebo
MT-5199 placebo capsules

Experimental: MT-5199 80 mg (Double-Blind Extension Period)
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.
Drug: MT-5199
MT-5199 40 mg capsules

Drug: Placebo
MT-5199 placebo capsules




Primary Outcome Measures :
  1. Severity of tardive dyskinesia (TD) symptoms assessed by Abnormal Involuntary Movements Scale (AIMS), change from baseline [ Time Frame: Baseline, Week 6 ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176771


Contacts
Contact: Clinical Trials Information Desk, to prevent miscommunication, please email: cti-inq-ml@ml.mt-pharma.co.jp

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Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03176771     History of Changes
Other Study ID Numbers: MT-5199-J02
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced