ME2112 Phase III (ME2112-2)
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080222769
- Lead Sponsor
- Meiji Seika Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 400
1)Patients with a diagnosis of schizophrenia as defined by DSM-5.
2)Written consent can be obtained from the patient.
3)Patient's condition is confirmed to be the acute exacerbation period of schizophrenia by the investigator or sub-investigator.
etc.
1)Total PANSS score has decreased by 20% or more from screening to baseline.
2)Patients of treatment-refractory.
3)Patients with a history or a complication of organic brain disorder.
4)Patients with a diagnosis of mental retardation or a personality disorder.
5)Patients with a risk of taking medicine compliance by the investigator or sub-investigator.
6)At screening, HbA1c (NGSP) level is 8.4% or higher.
7)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.
8)Patients with a serious cardiovascular disorders.
9)Patients with a risk of QT interval extension.
10)Patients with a Fridericia's corrected QT interval (QTcF) of 450 msec or longer.
11)Patients with a history of malignant syndrome.
12)Patients with a complication of Parkinson's disease.
13)Patients with a Tardive dyskinesia.
14)Patients with a risk of suicide as determined by the investigator or sub-investigator.
15)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 efficacy<br>PANSS total score.<br>Change in PANSS total score from baseline to the end of treatment (at Week 6 of treatment phase or Discontinuuation.)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>PANSS subscore.<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.<br>Incidence of adverse events.