Confirmatory Study of DSP-5423P in Patients With Schizophrenia

NCT02287584 | Completed Phase 3 Results

• 2 other identifiers: D4904020JapicCTI-142688
• Study Type: interventional
• Target: 580
• Locations: 8 countries
• Sites: 8

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• Treatment Continuation Rate at 28 Weeks and 52 Weeks

  Open-Week 28 and Open-Week 52 in the open-label treatment phase

Study Arms (5)

DSP-5423P Placebo

PLACEBO COMPARATOR

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

DSP-5423P 40mg

EXPERIMENTAL

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

DSP-5423P 80mg

EXPERIMENTAL

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

DSP-5423P Placebo-to-Flex

EXPERIMENTAL

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

DSP-5423P Active-to-Flex

EXPERIMENTAL

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

Interventions

DSP-5423P Placebo DRUG

DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily

DSP-5423P Placebo

DSP-5423P 40mg DRUG

DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P 40mg

DSP-5423P 80mg DRUG

DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P 80mg

DSP-5423P Placebo-to-Flex DRUG

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 Placebo-to-Flex

DSP-5423P Active-to-Flex DRUG

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

DSP-5423P Active-to-Flex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who fall under a contraindication listed in the blonanserin (LONASEN) package insert
• Patients with Parkinson disease
• Patients who previously received blonanserin, etc.

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (8)

3 Sites

Beijing, Etc., China

Location

53 Sites

Tokyo Etc., Japan

Location

14 Sites

Kuala Lumpur, Etc., Malaysia

Location

9 Sites

Manila, Etc., Philippines

Location

8 Sites

Smolensk, Etc, Russia

Location

7 Sites

Seoul, Etc., South Korea

Location

6 Sites

Taipei, Etc., Taiwan

Location

8 Sites

Poltava, Etc, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Research
• Organization: Sumitomo Dainippon Pharmaceutical

cc@ds-pharma.co.jp

+81-3-5159-2519

Study Officials

• Director, Drug Development Division

  Sumitomo Pharma Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 10, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 12, 2022
• Results First Posted: December 23, 2020

Record last verified: 2022-04

Locations

RU (1); JP (1); CN (1); PH (1); MY (1); TW (1); KR (1); UA (1)