Schizophrenia
Conditions
Brief summary
The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.
Interventions
DRUGDSP-5423P
40-80mg/day
Sponsors
Sumitomo Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSP-5423P (Cohort 1) Percutaneous
DSP-5423P: 40-80mg/day | 97 |
| DSP-5423P (Cohort 2) Percutaneous
DSP-5423P: 40-80mg/day | 103 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 18 | 12 |
| Overall Study | Lack of Efficacy | 4 | 5 |
| Overall Study | non-compliance | 2 | 3 |
| Overall Study | other reason | 2 | 3 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 21 |
Baseline characteristics
| Characteristic | DSP-5423P (Cohort 2) | Total | DSP-5423P (Cohort 1) |
|---|---|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 12.63 | 43.8 years STANDARD_DEVIATION 13.5 | 44.1 years STANDARD_DEVIATION 14.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 200 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 103 Participants | 200 Participants | 97 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 103 participants | 200 participants | 97 participants |
| Sex: Female, Male Female | 55 Participants | 109 Participants | 54 Participants |
| Sex: Female, Male Male | 48 Participants | 91 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 103 | 0 / 200 |
| other Total, other adverse events | 82 / 97 | 92 / 103 | 174 / 200 |
| serious Total, serious adverse events | 6 / 97 | 6 / 103 | 12 / 200 |
Outcome results
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.
Time frame: week 52
Population: Safety population-received at least one dose of study medication
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSP-5423P (Cohort 1) | Adverse Events and Adverse Drug Reactions, Etc. | Subjects with any AE | 82 Participants |
| DSP-5423P (Cohort 1) | Adverse Events and Adverse Drug Reactions, Etc. | Subjects with any treatment-related ADR | 60 Participants |
| DSP-5423P (Cohort 2) | Adverse Events and Adverse Drug Reactions, Etc. | Subjects with any treatment-related ADR | 77 Participants |
| DSP-5423P (Cohort 2) | Adverse Events and Adverse Drug Reactions, Etc. | Subjects with any AE | 92 Participants |
| DSP-5423P (Overall) | Adverse Events and Adverse Drug Reactions, Etc. | Subjects with any AE | 174 Participants |
| DSP-5423P (Overall) | Adverse Events and Adverse Drug Reactions, Etc. | Subjects with any treatment-related ADR | 137 Participants |
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.
Time frame: Week 52, Week 52 (LOCF)
Population: Safety population-received at least one dose of study medication
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DSP-5423P (Cohort 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 | Baseline | 63.6 units on a scale | Standard Deviation 21.23 |
| DSP-5423P (Cohort 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 | Change at Week 52 | -3.5 units on a scale | Standard Deviation 8.41 |
| DSP-5423P (Cohort 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 | Change at Week 52 (LOCF) | -0.1 units on a scale | Standard Deviation 11.59 |
| DSP-5423P (Cohort 2) | Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline | Baseline | 67.5 units on a scale | Standard Deviation 21.34 |
| DSP-5423P (Cohort 2) | Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline | Change at Week 52 | -9.2 units on a scale | Standard Deviation 15.08 |
| DSP-5423P (Cohort 2) | Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline | Change at Week 52 (LOCF) | -3.4 units on a scale | Standard Deviation 15.3 |