Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Sponsor
Sumitomo Pharma Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02287584
Collaborator
(none)
580
8
5
48
72.5
1.5
Study Details
Study Description
Brief Summary
The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
580 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Study Start Date
:
Dec 1, 2014
Actual Primary Completion Date
:
Dec 1, 2018
Actual Study Completion Date
:
Dec 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: DSP-5423P Placebo 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. |
Drug: DSP-5423P Placebo
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
| Experimental: DSP-5423P 40mg 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. |
Drug: DSP-5423P 40mg
DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
| Experimental: DSP-5423P 80mg 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. |
Drug: DSP-5423P 80mg
DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
| Experimental: DSP-5423P Placebo-to-Flex 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. |
Drug: DSP-5423P Placebo-to-Flex
DSP-5423P Placebo:
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
|
| Experimental: DSP-5423P Active-to-Flex 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. |
Drug: DSP-5423P Active-to-Flex
DSP-5423P Active:
DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
|
Outcome Measures
Primary Outcome Measures
- Change in PANSS Total Score From Baseline at Week 6 [Week 6]
The Positive and Negative Syndrome Scale (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.
Secondary Outcome Measures
- Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 [Week 6 (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 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 Last Observation Carried Forward (LOCF) endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P.
- Treatment Continuation Rate at 28 Weeks and 52 Weeks [Open-Week 28 and Open-Week 52 in the open-label treatment phase]
Percentage of subjects who stay the study up to 28 weeks (196 days, all countries), and 52 weeks (364 days, in Japan) and its 95% confidence interval.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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 blonanserin (LONASEN) package insert
-
Patients with Parkinson disease
-
Patients who previously received blonanserin, etc.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 3 Sites | Beijing, Etc. | China | ||
| 2 | 53 Sites | Tokyo Etc. | Japan | ||
| 3 | 7 Sites | Seoul, Etc. | Korea, Republic of | ||
| 4 | 14 Sites | Kuala Lumpur, Etc. | Malaysia | ||
| 5 | 9 Sites | Manila, etc. | Philippines | ||
| 6 | 8 Sites | Smolensk, Etc | Russian Federation | ||
| 7 | 6 Sites | Taipei, Etc. | Taiwan | ||
| 8 | 8 Sites | Poltava, Etc | Ukraine |
Sponsors and Collaborators
- Sumitomo Pharma Co., Ltd.
Investigators
- Study Director: Director, Drug Development Division, Sumitomo Pharma Co., Ltd.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Sumitomo Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02287584
Other Study ID Numbers:
- D4904020
- JapicCTI-142688
First Posted:
Nov 10, 2014
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were conducted in 8 countries/region between December 2014 and October 2018. |
|---|---|
| Pre-assignment Detail | In this study, 675 subjects provided informed consent, 580 of 606 subjects. |
| Arm/Group Title | DSP-5423P Placebo | DSP-5423P 40mg | DSP-5423P 80mg | DSP-5423P Placebo-to-Flex | DSP-5423P 40mg-to-Flex | DSP-5423P 80mg-to-Flex |
|---|---|---|---|---|---|---|
| Arm/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. DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily | 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 once daily. DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day. | 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 once daily. DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day. | 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 once daily. DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day. |
| Period Title: the Double-blind Phase | ||||||
| STARTED | 190 | 196 | 194 | 0 | 0 | 0 |
| COMPLETED | 138 | 149 | 161 | 0 | 0 | 0 |
| NOT COMPLETED | 52 | 47 | 33 | 0 | 0 | 0 |
| Period Title: the Double-blind Phase | ||||||
| STARTED | 0 | 0 | 0 | 138 | 149 | 161 |
| Treated | 0 | 0 | 0 | 131 | 143 | 157 |
| COMPLETED | 0 | 0 | 0 | 81 | 87 | 104 |
| NOT COMPLETED | 0 | 0 | 0 | 57 | 62 | 57 |
Baseline Characteristics
| Arm/Group Title | DSP-5423P Placebo | DSP-5423P 40mg | DSP-5423P 80mg | Total |
|---|---|---|---|---|
| Arm/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. DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily | Total of all reporting groups |
| Overall Participants | 189 | 196 | 192 | 577 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
41.5
(13.67)
|
40.7
(13.34)
|
40.7
(14.35)
|
41.0
(13.77)
|
| Age, Customized (Count of Participants) | ||||
| <65 |
176
93.1%
|
185
94.4%
|
180
93.8%
|
541
93.8%
|
| >=65 |
13
6.9%
|
11
5.6%
|
12
6.3%
|
36
6.2%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
76
40.2%
|
80
40.8%
|
78
40.6%
|
234
40.6%
|
| Male |
113
59.8%
|
116
59.2%
|
114
59.4%
|
343
59.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
189
100%
|
196
100%
|
192
100%
|
577
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
161
85.2%
|
167
85.2%
|
165
85.9%
|
493
85.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
28
14.8%
|
29
14.8%
|
27
14.1%
|
84
14.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| South Korea |
7
3.7%
|
7
3.6%
|
7
3.6%
|
21
3.6%
|
| Japan |
51
27%
|
55
28.1%
|
56
29.2%
|
162
28.1%
|
| Philippines |
25
13.2%
|
22
11.2%
|
22
11.5%
|
69
12%
|
| China |
9
4.8%
|
9
4.6%
|
10
5.2%
|
28
4.9%
|
| Taiwan |
14
7.4%
|
15
7.7%
|
17
8.9%
|
46
8%
|
| Ukraine |
14
7.4%
|
17
8.7%
|
15
7.8%
|
46
8%
|
| Malaysia |
55
29.1%
|
58
29.6%
|
53
27.6%
|
166
28.8%
|
| Russia |
14
7.4%
|
13
6.6%
|
12
6.3%
|
39
6.8%
|
| Positive and Negative Syndrome Scale (PANSS) total score (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
99.5
(13.84)
|
101.6
(15.55)
|
101.5
(14.76)
|
100.9
(14.75)
|
Outcome Measures
| Title | Change in PANSS Total Score From Baseline at Week 6 |
|---|---|
| Description | The Positive and Negative Syndrome Scale (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. |
| Time Frame | Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified Intention-to-treat (mITT) population; Change in PANSS Total Score Using Mixed Model for Repeated Measures in the Double-Blind Treatment Phase |
| Arm/Group Title | DSP-5423P Placebo | DSP-5423P 40mg | DSP-5423P 80mg |
|---|---|---|---|
| Arm/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. DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily |
| Measure Participants | 189 | 196 | 192 |
| baseline mean(SD) |
99.5
(13.84)
|
101.6
(15.55)
|
101.5
(14.76)
|
| Change at Week 6 |
-10.8
(1.47)
|
-16.4
(1.43)
|
-21.3
(1.41)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DSP-5423P Placebo, DSP-5423P 40mg |
|---|---|---|
| Comments | Using Mixed Model for Repeated Measures | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | adjusted p value, Hochberg procedure | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.6 | |
| Confidence Interval |
(2-Sided) 95% -9.6 to -1.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.04 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DSP-5423P Placebo, DSP-5423P 80mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | adjusted p-value, Hochberg procedure | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -10.4 | |
| Confidence Interval |
(2-Sided) 95% -14.4 to -6.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.03 |
|
| Estimation Comments | ||
| Title | Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 |
|---|---|
| Description | 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 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 Last Observation Carried Forward (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 6 (LOCF) |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified Intention-to-treat (mITT) population |
| Arm/Group Title | DSP-5423P Placebo | DSP-5423P 40mg | DSP-5423P 80mg |
|---|---|---|---|
| Arm/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. DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily |
| Measure Participants | 189 | 196 | 192 |
| >=20% improvement from baseline |
80
42.3%
|
99
50.5%
|
107
55.7%
|
| >=30% improvement from baseline |
52
27.5%
|
72
36.7%
|
80
41.7%
|
| >=40% improvement from baseline |
32
16.9%
|
49
25%
|
55
28.6%
|
| >=50% improvement from baseline |
15
7.9%
|
25
12.8%
|
40
20.8%
|
| Title | Treatment Continuation Rate at 28 Weeks and 52 Weeks |
|---|---|
| Description | Percentage of subjects who stay the study up to 28 weeks (196 days, all countries), and 52 weeks (364 days, in Japan) and its 95% confidence interval. |
| Time Frame | Open-Week 28 and Open-Week 52 in the open-label treatment phase |
Outcome Measure Data
| Analysis Population Description |
|---|
| Open-label population: all subjects who applied DSP-5423P at least once in the open-label treatment phase. |
| Arm/Group Title | DSP-5423P Placebo-to-Flex | DSP-5423P 40 Mg-to-Flex | DSP-5423P 80 Mg-to-Flex |
|---|---|---|---|
| Arm/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. | Percutaneous Subjects received DSP-5423P 40 mg 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. | Percutaneous Subjects received DSP-5423P 80 mg 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. |
| Measure Participants | 131 | 143 | 157 |
| 28 weeks (196 days, all countries) |
64.4
|
62.9
|
70.7
|
| 52 weeks (364 days, in Japan) |
44.4
|
51.5
|
50.0
|
Adverse Events
| Time Frame | Up to 58 weeks | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study. | |||||||||||
| Arm/Group Title | DSP-5423P Placebo | DSP-5423P 40mg | DSP-5423P 80mg | DSP-5423P Placebo-to-Flex | DSP-5423P 40mg-to-Flex | DSP-5423P 80mg-to-Flex | ||||||
| Arm/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. DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily | 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. DSP-5423P Placebo-to-Flex: DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily DSP-5423P Flex: DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily | Percutaneous Subjects received DSP-5423P 40mg 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. DSP-5423P Active-to-Flex: DSP-5423P Active: DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily DSP-5423P Flex: DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily | Percutaneous Subjects received DSP-5423P 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. | ||||||
All Cause Mortality |
||||||||||||
| DSP-5423P Placebo | DSP-5423P 40mg | DSP-5423P 80mg | DSP-5423P Placebo-to-Flex | DSP-5423P 40mg-to-Flex | DSP-5423P 80mg-to-Flex | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/190 (0%) | 0/196 (0%) | 1/194 (0.5%) | 1/131 (0.8%) | 0/196 (0%) | 4/194 (2.1%) | ||||||
Serious Adverse Events |
||||||||||||
| DSP-5423P Placebo | DSP-5423P 40mg | DSP-5423P 80mg | DSP-5423P Placebo-to-Flex | DSP-5423P 40mg-to-Flex | DSP-5423P 80mg-to-Flex | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/190 (4.7%) | 8/196 (4.1%) | 10/194 (5.2%) | 18/131 (13.7%) | 24/196 (12.2%) | 29/194 (14.9%) | ||||||
| Cardiac disorders | ||||||||||||
| Acute myocardial infarction | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Gastrointestinal disorders | ||||||||||||
| Colitis | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Upper gastrointestinal haemorrhage | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 1/131 (0.8%) | 1 | 0/196 (0%) | 0 | 0/194 (0%) | 0 |
| General disorders | ||||||||||||
| Death | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Sudden death | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 1/131 (0.8%) | 1 | 0/196 (0%) | 0 | 0/194 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| Bile duct stone | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Infections and infestations | ||||||||||||
| Bartholin's abscess | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 |
| Intervertebral discitis | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Pneumonia | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Pulmonary tuberculosis | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||
| Comminuted fracture | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 |
| Femoral neck fracture | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 |
| Humerus fracture | 0/190 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 |
| Toxicity to various agents | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 1/131 (0.8%) | 1 | 0/196 (0%) | 0 | 2/194 (1%) | 2 |
| Traumatic haematoma | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Investigations | ||||||||||||
| Weight increased | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 1/131 (0.8%) | 1 | 0/196 (0%) | 0 | 0/194 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Intervertebral disc protrusion | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Akathisia | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 2/196 (1%) | 2 | 0/194 (0%) | 0 |
| Generalised tonic-clonic seizure | 0/190 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 |
| Guillain-Barre syndrome | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Loss of consciousness | 1/190 (0.5%) | 1 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 |
| Psychiatric disorders | ||||||||||||
| Abnormal behaviour | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Aggression | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Catatonia | 1/190 (0.5%) | 1 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 |
| Completed suicide | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Hallucination | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Psychiatric symptom | 0/190 (0%) | 0 | 1/196 (0.5%) | 1 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 2/196 (1%) | 3 | 1/194 (0.5%) | 1 |
| Psychotic disorder | 2/190 (1.1%) | 2 | 1/196 (0.5%) | 1 | 1/194 (0.5%) | 1 | 4/131 (3.1%) | 4 | 2/196 (1%) | 2 | 1/194 (0.5%) | 2 |
| Schizophrenia | 4/190 (2.1%) | 4 | 4/196 (2%) | 4 | 2/194 (1%) | 2 | 9/131 (6.9%) | 9 | 10/196 (5.1%) | 11 | 10/194 (5.2%) | 11 |
| Suicidal ideation | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 1/131 (0.8%) | 1 | 2/196 (1%) | 2 | 0/194 (0%) | 0 |
| Suicide attempt | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 | 0/131 (0%) | 0 | 1/196 (0.5%) | 1 | 1/194 (0.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Asthma | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Choking | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Social circumstances | ||||||||||||
| Social stay hospitalisation | 1/190 (0.5%) | 1 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
| Vascular disorders | ||||||||||||
| Hypotension | 0/190 (0%) | 0 | 0/196 (0%) | 0 | 0/194 (0%) | 0 | 0/131 (0%) | 0 | 0/196 (0%) | 0 | 1/194 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| DSP-5423P Placebo | DSP-5423P 40mg | DSP-5423P 80mg | DSP-5423P Placebo-to-Flex | DSP-5423P 40mg-to-Flex | DSP-5423P 80mg-to-Flex | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 45/190 (23.7%) | 62/196 (31.6%) | 76/194 (39.2%) | 60/131 (45.8%) | 108/196 (55.1%) | 111/194 (57.2%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Constipation | 5/190 (2.6%) | 5 | 8/196 (4.1%) | 9 | 8/194 (4.1%) | 9 | 6/131 (4.6%) | 8 | 8/196 (4.1%) | 11 | 13/194 (6.7%) | 18 |
| Salivary hypersecretion | 1/190 (0.5%) | 1 | 0/196 (0%) | 0 | 4/194 (2.1%) | 4 | 3/131 (2.3%) | 3 | 5/196 (2.6%) | 6 | 10/194 (5.2%) | 12 |
| General disorders | ||||||||||||
| Application site erythema | 3/190 (1.6%) | 4 | 11/196 (5.6%) | 17 | 18/194 (9.3%) | 33 | 8/131 (6.1%) | 12 | 12/196 (6.1%) | 22 | 23/194 (11.9%) | 43 |
| Application site pruritus | 1/190 (0.5%) | 1 | 10/196 (5.1%) | 11 | 14/194 (7.2%) | 14 | 4/131 (3.1%) | 5 | 14/196 (7.1%) | 15 | 19/194 (9.8%) | 20 |
| Infections and infestations | ||||||||||||
| Nasopharyngitis | 8/190 (4.2%) | 8 | 5/196 (2.6%) | 8 | 9/194 (4.6%) | 9 | 11/131 (8.4%) | 11 | 14/196 (7.1%) | 27 | 25/194 (12.9%) | 32 |
| Upper respiratory tract infection | 1/190 (0.5%) | 1 | 4/196 (2%) | 6 | 3/194 (1.5%) | 3 | 7/131 (5.3%) | 10 | 11/196 (5.6%) | 14 | 5/194 (2.6%) | 7 |
| Investigations | ||||||||||||
| Weight increased | 6/190 (3.2%) | 6 | 3/196 (1.5%) | 3 | 3/194 (1.5%) | 3 | 16/131 (12.2%) | 16 | 13/196 (6.6%) | 13 | 13/194 (6.7%) | 13 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Muscle rigidity | 0/190 (0%) | 0 | 3/196 (1.5%) | 3 | 7/194 (3.6%) | 7 | 4/131 (3.1%) | 4 | 5/196 (2.6%) | 6 | 11/194 (5.7%) | 12 |
| Nervous system disorders | ||||||||||||
| Akathisia | 2/190 (1.1%) | 2 | 11/196 (5.6%) | 11 | 19/194 (9.8%) | 22 | 11/131 (8.4%) | 14 | 22/196 (11.2%) | 27 | 27/194 (13.9%) | 34 |
| Bradykinesia | 0/190 (0%) | 0 | 1/196 (0.5%) | 1 | 6/194 (3.1%) | 6 | 1/131 (0.8%) | 1 | 6/196 (3.1%) | 6 | 11/194 (5.7%) | 11 |
| Headache | 5/190 (2.6%) | 5 | 9/196 (4.6%) | 10 | 7/194 (3.6%) | 7 | 6/131 (4.6%) | 6 | 13/196 (6.6%) | 21 | 17/194 (8.8%) | 35 |
| Tremor | 5/190 (2.6%) | 5 | 8/196 (4.1%) | 9 | 17/194 (8.8%) | 18 | 9/131 (6.9%) | 9 | 14/196 (7.1%) | 15 | 27/194 (13.9%) | 33 |
| Psychiatric disorders | ||||||||||||
| Insomnia | 9/190 (4.7%) | 10 | 10/196 (5.1%) | 12 | 10/194 (5.2%) | 11 | 5/131 (3.8%) | 28 | 22/196 (11.2%) | 32 | 20/194 (10.3%) | 29 |
| Schizophrenia | 10/190 (5.3%) | 10 | 6/196 (3.1%) | 6 | 1/194 (0.5%) | 1 | 3/131 (2.3%) | 3 | 13/196 (6.6%) | 13 | 5/194 (2.6%) | 5 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Research |
|---|---|
| Organization | Sumitomo Dainippon Pharmaceutical |
| Phone | +81-3-5159-2519 |
| cc@ds-pharma.co.jp |
Responsible Party:
Sumitomo Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02287584
Other Study ID Numbers:
- D4904020
- JapicCTI-142688
First Posted:
Nov 10, 2014
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022