Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287584
• Other study ID #: D4904020
• Secondary ID: JapicCTI-142688
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2022
• Source: Sumitomo Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• DSP-5423P Placebo
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
• DSP-5423P 40mg
DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
• DSP-5423P 80mg
DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
• DSP-5423P Placebo-to-Flex
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
• DSP-5423P Active-to-Flex
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

Locations

Country	Name	City	State
China	3 Sites	Beijing, Etc.
Japan	53 Sites	Tokyo Etc.
Korea, Republic of	7 Sites	Seoul, Etc.
Malaysia	14 Sites	Kuala Lumpur, Etc.
Philippines	9 Sites	Manila, etc.
Russian Federation	8 Sites	Smolensk, Etc
Taiwan	6 Sites	Taipei, Etc.
Ukraine	8 Sites	Poltava, Etc

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Co., Ltd.

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of,  Malaysia,  Philippines,  Russian Federation,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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