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Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DSP-5423P Placebo
DSP-5423P 40mg
DSP-5423P 80mg
DSP-5423P Placebo-to-Flex
DSP-5423P Active-to-Flex
Sponsored by
Sumitomo Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 3 Sites
  • 53 Sites
  • 7 Sites
  • 14 Sites
  • 9 Sites
  • 8 Sites
  • 6 Sites
  • 8 Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

DSP-5423P Placebo

DSP-5423P 40mg

DSP-5423P 80mg

DSP-5423P Placebo-to-Flex

DSP-5423P Active-to-Flex

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 6, 2014
Last Updated
April 9, 2022
Sponsor
Sumitomo Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02287584
Brief Title
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Official Title
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DSP-5423P Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
DSP-5423P 40mg
Arm Type
Experimental
Arm Description
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.
Arm Title
DSP-5423P 80mg
Arm Type
Experimental
Arm Description
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.
Arm Title
DSP-5423P Placebo-to-Flex
Arm Type
Experimental
Arm Description
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.
Arm Title
DSP-5423P Active-to-Flex
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DSP-5423P Placebo
Intervention Description
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
Intervention Type
Drug
Intervention Name(s)
DSP-5423P 40mg
Intervention Description
DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
Intervention Type
Drug
Intervention Name(s)
DSP-5423P 80mg
Intervention Description
DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
Intervention Type
Drug
Intervention Name(s)
DSP-5423P Placebo-to-Flex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
DSP-5423P Active-to-Flex
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in PANSS Total Score From Baseline at Week 6
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Week 6 (LOCF)
Title
Treatment Continuation Rate at 28 Weeks and 52 Weeks
Description
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.
Time Frame
Open-Week 28 and Open-Week 52 in the open-label treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director, Drug Development Division
Organizational Affiliation
Sumitomo Pharma Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
3 Sites
City
Beijing, Etc.
Country
China
Facility Name
53 Sites
City
Tokyo Etc.
Country
Japan
Facility Name
7 Sites
City
Seoul, Etc.
Country
Korea, Republic of
Facility Name
14 Sites
City
Kuala Lumpur, Etc.
Country
Malaysia
Facility Name
9 Sites
City
Manila, etc.
Country
Philippines
Facility Name
8 Sites
City
Smolensk, Etc
Country
Russian Federation
Facility Name
6 Sites
City
Taipei, Etc.
Country
Taiwan
Facility Name
8 Sites
City
Poltava, Etc
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Confirmatory Study of DSP-5423P in Patients With Schizophrenia

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