ME2112 Phase III (ME2112-3)

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: JPRN-jRCT2080222770
• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-26
• Study Completion: 2019-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1)Patients with a diagnosis of schizophrenia as defined by DSM-5.
2)Written consent can be obtained from the patient.
3)The patient has completed the 6-week treatment phase in the preceding short-term study (ME2112-2 study), has exhibited efficacy, has no significant safety issue, and has been judged by the investigator to be suitable for participation in this study.
4)Patients of treatment-refractory, or elderly patients aged 65 years or older
etc.

Exclusion Criteria

1)Patients with a history or a complication of organic brain disorder.
2)Patients with a diagnosis of mental retardation or a personality disorder.
3)At screening, HbA1c (NGSP)level is 8.4% or higher.
4)Patients undergoing drug therapy complicated by uncontrolled liver disease, kidney disease, respiratory disease, gastrointestinal disease, hematologic disease, endocrine disease, metabolic disease, or cranial nerve disease or other clinically significant progressive physical disease.
5)Patients with a serious cardiovascular disorders.
6)Patients with a risk of QT interval extension.
7)Patients with a Fridericia's corrected QT interval (QTcF) of 450 msec or longer.
8)Patients with a history of malignant syndrome.
9)Patients with a complication of Parkinson's disease.
10)Patients with a Tardive dyskinesia.
11)Patients with a risk of suicide as determined by the investigator or sub-investigator.
12)Female patients who are pregnant, nursing, or potentially pregnant, who wishes to become pregnant, or a male patients whose partner wish to become pregnant.
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Adverse events<br>Incidence of adverse events

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>PANSS score.<br>Clinical Global Impression-Severity of illness (CGI-S).<br>Clinical Global Impression-Global Improvement (CGI-I).<br>Change in PANSS subscore from baseline, and the PANSS responder rate.<br>Change in CGI-S score.<br>CGI-I response rate.<br>Adverse events.