Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: DSP-5423P Active-to-Flex; Drug: DSP-5423P 80mg; Drug: DSP-5423P 40mg; Drug: DSP-5423P Placebo; Drug: DSP-5423P Placebo-to-Flex

Study type: Interventional

Funder types: Industry

Identifiers

NCT02287584

D4904020

JapicCTI-142688 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 580 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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580 participants in 5 patient groups, including a placebo group

DSP-5423P Placebo

Placebo Comparator group

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.

Treatment:

Drug: DSP-5423P Placebo

DSP-5423P 40mg

Experimental group

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.

Treatment:

Drug: DSP-5423P 40mg

DSP-5423P 80mg

Experimental group

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.

Treatment:

Drug: DSP-5423P 80mg

DSP-5423P Placebo-to-Flex

Experimental group

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.

Treatment:

Drug: DSP-5423P Placebo-to-Flex

DSP-5423P Active-to-Flex

Experimental group

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.

Treatment:

Drug: DSP-5423P Active-to-Flex