Long-term Study of DSP-5423P in Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: DSP-5423P

• Registration Number: NCT02335658
• Lead Sponsor: Sumitomo Pharma Co., Ltd.

Brief Summary

The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Results First Submitted: 2020-08-31
• Results First Submitted QC: 2020-10-28
• Results First Posted: 2020-11-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 LONASEN® package insert
• Patients with Parkinson disease, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DSP-5423P	DSP-5423P	Percutaneous

Primary Outcome Measures

Name	Time	Method
Adverse Events and Adverse Drug Reactions, Etc.	week 52	Number of Subjects With Adverse Event (AE) and Adverse Drug Reaction (ADR) An adverse event (AE) is any untoward medical occurrence in a study subject administered a medicinal (investigational) product and which does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.; An adverse drug reaction (ADR) is any AE which has a causal relationship with this treatment.

Secondary Outcome Measures

Name	Time	Method
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline	Week 52, Week 52 (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 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.; The LOCF endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P.

Trial Locations

Locations (1)

38 Sites; 🇯🇵 Tokyo, Japan