Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: DSP-5423P 40mg; Drug: DSP-5423P Active-to-Flex; Drug: DSP-5423P Placebo; Drug: DSP-5423P 80mg; Drug: DSP-5423P Placebo-to-Flex

• Registration Number: NCT02287584
• Lead Sponsor: Sumitomo Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-10
• Study Start: 2014-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Results First Submitted: 2020-08-31
• Results First Submitted QC: 2020-12-01
• Results First Posted: 2020-12-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DSP-5423P 40mg	DSP-5423P 40mg	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.
DSP-5423P Active-to-Flex	DSP-5423P Active-to-Flex	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.
DSP-5423P Placebo	DSP-5423P Placebo	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.
DSP-5423P 80mg	DSP-5423P 80mg	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.
DSP-5423P Placebo-to-Flex	DSP-5423P Placebo-to-Flex	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.

Primary Outcome Measures

Name	Time	Method
Change in PANSS Total Score From Baseline at Week 6	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

Name	Time	Method
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	Week 6 (LOCF)	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	Open-Week 28 and Open-Week 52 in the open-label treatment phase	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.

Trial Locations

Locations (7)

53 Sites; 🇯🇵 Tokyo Etc., Japan

3 Sites; 🇨🇳 Beijing, Etc., China

7 Sites; 🇰🇷 Seoul, Etc., Korea, Republic of

14 Sites; 🇲🇾 Kuala Lumpur, Etc., Malaysia

9 Sites; 🇵🇭 Manila, etc., Philippines

8 Sites; 🇺🇦 Poltava, Etc, Ukraine

6 Sites; 🇨🇳 Taipei, Etc., Taiwan