Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.

Official Title
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Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: DSP-5423P Placebo
* Drug: DSP-5423P 40mg
* Drug: DSP-5423P 80mg
* Drug: DSP-5423P Placebo-to-Flex
* Drug: DSP-5423P Active-to-Flex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria Patients who are aged 18 years or older at informed consent Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc. Exclusion Criteria: Patients who fall under a contraindication listed in the blonanserin (LONASEN) package insert Patients with Parkinson disease Patients who previously received blonanserin, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: DSP-5423P Placebo<br>Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. | Drug: DSP-5423P Placebo<br>* DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily<br>|
| Experimental: DSP-5423P 40mg<br>Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. | Drug: DSP-5423P 40mg<br>* DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily<br>|
| Experimental: DSP-5423P 80mg<br>Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. | Drug: DSP-5423P 80mg<br>* DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily<br>|
| Experimental: DSP-5423P Placebo-to-Flex<br>Percutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen. | Drug: DSP-5423P Placebo-to-Flex<br>* DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily DSP-5423P Flex: DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily<br>|
| Experimental: DSP-5423P Active-to-Flex<br>Percutaneous Subjects received DSP-5423P 40mg or 80mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen. | Drug: DSP-5423P Active-to-Flex<br>* DSP-5423P Active: DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily DSP-5423P Flex: DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PANSS Total Score From Baseline at Week 6 | The Positive and Negative Syndrome Scale (PANSS) is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. The Last Observation Carried Forward (LOCF) endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P. | Week 6 (LOCF) | 
| Treatment Continuation Rate at 28 Weeks and 52 Weeks | Percentage of subjects who stay the study up to 28 weeks (196 days, all countries), and 52 weeks (364 days, in Japan) and its 95% confidence interval. | Open-Week 28 and Open-Week 52 in the open-label treatment phase |