Long-term Study of DSP-5423P in Patients With Schizophrenia
2 other identifiers
interventional
200
1 country
1
Brief Summary
The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Dec 2014
Typical duration for phase_3 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 7, 2015
CompletedFirst Posted
Study publicly available on registry
January 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
November 19, 2020
CompletedApril 12, 2022
April 1, 2022
2.4 years
January 7, 2015
August 31, 2020
April 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events and Adverse Drug Reactions, Etc.
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.
week 52
Secondary Outcomes (1)
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)
Study Arms (1)
DSP-5423P
EXPERIMENTALPercutaneous
Interventions
Eligibility Criteria
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 LONASEN® package insert
- Patients with Parkinson disease, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
38 Sites
Tokyo, Japan
Related Publications (1)
Iwata N, Ishigooka J, Naoi I, Matsumoto M, Kanamori Y, Nakamura H, Higuchi T. Long-Term Safety and Efficacy of Blonanserin Transdermal Patches in Japanese Patients with Schizophrenia: A 52-Week Open-Label, Multicenter Study. CNS Drugs. 2020 Jan;34(1):103-116. doi: 10.1007/s40263-019-00692-6.
PMID: 31883082DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research
- Organization
- Sumitomo Dainippon Pharmaceutical
Study Officials
- STUDY DIRECTOR
Director, Drug Development Division
Sumitomo Pharma Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2015
First Posted
January 12, 2015
Study Start
December 1, 2014
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
April 12, 2022
Results First Posted
November 19, 2020
Record last verified: 2022-04