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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-152765 | Registry Identifier | JAPIC Clinical Trials Informaton |
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The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSP-5423P | Experimental | Percutaneous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSP-5423P | Drug | 40-80mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director, Drug Development Division | Sumitomo Pharma Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 38 Sites | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31883082 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSP-5423P (Cohort 1) | Percutaneous DSP-5423P: 40-80mg/day, once daily The initial dose of DSP-5423P in Cohort 1 was corresponding to the final dose of DSP-5423 (tablet) in previous period. |
| FG001 | DSP-5423P (Cohort 2) | Percutaneous DSP-5423P: 40-80mg/day, once daily The initial dose of DSP-5423P in Cohort 2 was 40 mg/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population-received at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | DSP-5423P (Cohort 1) | Percutaneous DSP-5423P: 40-80mg/day |
| BG001 | DSP-5423P (Cohort 2) | Percutaneous DSP-5423P: 40-80mg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population-received at least one dose of study medication | Posted | Count of Participants | Participants | week 52 |
|
Adverse event data was collected for 52 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DSP-5423P (Cohort 1) | Percutaneous DSP-5423P: 40-80mg/day | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperprolactinaemia | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research | Sumitomo Dainippon Pharmaceutical | +81-3-5159-2519 | cc@ds-pharma.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2015 | Aug 31, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2017 | Aug 31, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Week 52, Week 52 (LOCF) |
| Pregnancy |
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| Withdrawal by Subject |
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| non-compliance |
|
| other reason |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Percutaneous DSP-5423P: 40-80mg/day |
| OG001 | DSP-5423P (Cohort 2) | Percutaneous DSP-5423P: 40-80mg/day |
| OG002 | DSP-5423P (Overall) | Percutaneous DSP-5423P: 40-80mg/day |
|
|
| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline | 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. | Safety population-received at least one dose of study medication | Posted | Mean | Standard Deviation | units on a scale | Week 52, Week 52 (LOCF) |
|
|
|
| 97 |
| 6 |
| 97 |
| 82 |
| 97 |
| EG001 | DSP-5423P (Cohort 2) | Percutaneous DSP-5423P: 40-80mg/day | 0 | 103 | 6 | 103 | 92 | 103 |
| EG002 | DSP-5423P (Overall) | Percutaneous DSP-5423P: 40-80mg/day Cohort 1 + Cohort 2 | 0 | 200 | 12 | 200 | 174 | 200 |
| Pneumonia haemophilus | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Impulse-control disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Application site dermatitis | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Blood prolactin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
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| Change at Week 52 (LOCF) |
|