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

Phase 2

Completed

• Conditions: Tardive Dyskinesia
• Interventions: Drug: MT-5199; Drug: Placebo

• Registration Number: NCT03176771
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Study Start: 2017-06-21
• Primary Completion: 2020-09-29
• Study Completion: 2020-09-29
• Results First Submitted: 2022-08-25
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-08
• Results First Posted: 2023-08-14
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6	Baseline and Week 6	Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder)	Week 6	Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6	Baseline and Week 6	Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded site AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6	Week 6	Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).

Trial Locations

Locations (82)

Aichi Psychiatric Medical Center; 🇯🇵 Aichi, Japan

Hotei Hospital; 🇯🇵 Aichi, Japan

Mikawa Hospital; 🇯🇵 Aichi, Japan

Okehazama Hospital Fujita Kokoro Care Center; 🇯🇵 Aichi, Japan

Akita City Hospital; 🇯🇵 Akita, Japan

Akita University Hospital; 🇯🇵 Akita, Japan

Hirosaki Aiseikai Hospital; 🇯🇵 Aomori, Japan

Minato Hospital; 🇯🇵 Aomori, Japan

Seinan Hospital; 🇯🇵 Aomori, Japan

Kohnodai Hospital , National Center for Global Health and Medicine; 🇯🇵 Chiba, Japan

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