Trial Outcomes & Findings for Long-term Study of DSP-5423P in Patients With Schizophrenia (NCT NCT02335658)

Last Updated: 2022-04-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

200 participants

Primary outcome timeframe

week 52

Results posted on

2022-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	97	103
Overall Study COMPLETED	57	59
Overall Study NOT COMPLETED	40	44

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Overall Study Adverse Event	18	12
Overall Study Lack of Efficacy	4	5
Overall Study Pregnancy	1	0
Overall Study Withdrawal by Subject	13	21
Overall Study non-compliance	2	3
Overall Study other reason	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DSP-5423P (Cohort 1) n=97 Participants Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Cohort 2) n=103 Participants Percutaneous DSP-5423P: 40-80mg/day	Total n=200 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 14.43 • n=5 Participants	43.6 years STANDARD_DEVIATION 12.63 • n=7 Participants	43.8 years STANDARD_DEVIATION 13.50 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants	103 Participants n=7 Participants	200 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	97 Participants n=5 Participants	103 Participants n=7 Participants	200 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	97 participants n=5 Participants	103 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: week 52

Population: Safety population-received at least one dose of study medication

Outcome measures

Outcome measures
Measure	DSP-5423P (Cohort 1) n=97 Participants Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Cohort 2) n=103 Participants Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Overall) n=200 Participants Percutaneous DSP-5423P: 40-80mg/day
Adverse Events and Adverse Drug Reactions, Etc. Subjects with any AE	82 Participants	92 Participants	174 Participants
Adverse Events and Adverse Drug Reactions, Etc. Subjects with any treatment-related ADR	60 Participants	77 Participants	137 Participants

SECONDARY outcome

Timeframe: Week 52, Week 52 (LOCF)

Population: Safety population-received at least one dose of study medication

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.

Outcome measures

Outcome measures
Measure	DSP-5423P (Cohort 1) n=97 Participants Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Cohort 2) n=103 Participants Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Overall) Percutaneous DSP-5423P: 40-80mg/day
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	67.5 units on a scale Standard Deviation 21.34	—
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	-9.2 units on a scale Standard Deviation 15.08	—
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	-3.4 units on a scale Standard Deviation 15.30	—

Adverse Events

DSP-5423P (Cohort 1)

Serious events: 6 serious events

Other events: 82 other events

Deaths: 0 deaths

DSP-5423P (Cohort 2)

Serious events: 6 serious events

Other events: 92 other events

Deaths: 0 deaths

DSP-5423P (Overall)

Serious events: 12 serious events

Other events: 174 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DSP-5423P (Cohort 1) n=97 participants at risk Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Cohort 2) n=103 participants at risk Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Overall) n=200 participants at risk Percutaneous DSP-5423P: 40-80mg/day Cohort 1 + Cohort 2
Infections and infestations Pneumonia	0.00% 0/97 • Adverse event data was collected for 52 weeks.	0.97% 1/103 • Number of events 1 • Adverse event data was collected for 52 weeks.	0.50% 1/200 • Number of events 1 • Adverse event data was collected for 52 weeks.
Infections and infestations Pneumonia haemophilus	0.00% 0/97 • Adverse event data was collected for 52 weeks.	0.97% 1/103 • Number of events 1 • Adverse event data was collected for 52 weeks.	0.50% 1/200 • Number of events 1 • Adverse event data was collected for 52 weeks.
Injury, poisoning and procedural complications Fracture	1.0% 1/97 • Number of events 1 • Adverse event data was collected for 52 weeks.	0.00% 0/103 • Adverse event data was collected for 52 weeks.	0.50% 1/200 • Number of events 1 • Adverse event data was collected for 52 weeks.
Psychiatric disorders Impulse-control disorder	1.0% 1/97 • Number of events 1 • Adverse event data was collected for 52 weeks.	0.00% 0/103 • Adverse event data was collected for 52 weeks.	0.50% 1/200 • Number of events 1 • Adverse event data was collected for 52 weeks.
Psychiatric disorders Schizophrenia	2.1% 2/97 • Number of events 2 • Adverse event data was collected for 52 weeks.	3.9% 4/103 • Number of events 4 • Adverse event data was collected for 52 weeks.	3.0% 6/200 • Number of events 6 • Adverse event data was collected for 52 weeks.
Respiratory, thoracic and mediastinal disorders Asthma	1.0% 1/97 • Number of events 1 • Adverse event data was collected for 52 weeks.	0.00% 0/103 • Adverse event data was collected for 52 weeks.	0.50% 1/200 • Number of events 1 • Adverse event data was collected for 52 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 1/97 • Number of events 1 • Adverse event data was collected for 52 weeks.	0.00% 0/103 • Adverse event data was collected for 52 weeks.	0.50% 1/200 • Number of events 1 • Adverse event data was collected for 52 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/97 • Adverse event data was collected for 52 weeks.	0.97% 1/103 • Number of events 1 • Adverse event data was collected for 52 weeks.	0.50% 1/200 • Number of events 1 • Adverse event data was collected for 52 weeks.

Other adverse events

Additional Information

Clinical Research

Sumitomo Dainippon Pharmaceutical

Phone: +81-3-5159-2519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DSP-5423P (Cohort 1) n=97 participants at risk Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Cohort 2) n=103 participants at risk Percutaneous DSP-5423P: 40-80mg/day	DSP-5423P (Overall) n=200 participants at risk Percutaneous DSP-5423P: 40-80mg/day Cohort 1 + Cohort 2
Nervous system disorders Tremor	4.1% 4/97 • Number of events 4 • Adverse event data was collected for 52 weeks.	9.7% 10/103 • Number of events 11 • Adverse event data was collected for 52 weeks.	7.0% 14/200 • Number of events 15 • Adverse event data was collected for 52 weeks.
Psychiatric disorders Insomnia	7.2% 7/97 • Number of events 7 • Adverse event data was collected for 52 weeks.	10.7% 11/103 • Number of events 11 • Adverse event data was collected for 52 weeks.	9.0% 18/200 • Number of events 18 • Adverse event data was collected for 52 weeks.
Endocrine disorders Hyperprolactinaemia	7.2% 7/97 • Number of events 8 • Adverse event data was collected for 52 weeks.	6.8% 7/103 • Number of events 7 • Adverse event data was collected for 52 weeks.	7.0% 14/200 • Number of events 15 • Adverse event data was collected for 52 weeks.
Gastrointestinal disorders Dental caries	5.2% 5/97 • Number of events 7 • Adverse event data was collected for 52 weeks.	7.8% 8/103 • Number of events 9 • Adverse event data was collected for 52 weeks.	6.5% 13/200 • Number of events 16 • Adverse event data was collected for 52 weeks.
Gastrointestinal disorders Diarrhoea	5.2% 5/97 • Number of events 5 • Adverse event data was collected for 52 weeks.	4.9% 5/103 • Number of events 7 • Adverse event data was collected for 52 weeks.	5.0% 10/200 • Number of events 12 • Adverse event data was collected for 52 weeks.
Gastrointestinal disorders Vomiting	7.2% 7/97 • Number of events 8 • Adverse event data was collected for 52 weeks.	2.9% 3/103 • Number of events 4 • Adverse event data was collected for 52 weeks.	5.0% 10/200 • Number of events 12 • Adverse event data was collected for 52 weeks.
General disorders Application site dermatitis	8.2% 8/97 • Number of events 8 • Adverse event data was collected for 52 weeks.	1.9% 2/103 • Number of events 9 • Adverse event data was collected for 52 weeks.	5.0% 10/200 • Number of events 17 • Adverse event data was collected for 52 weeks.
General disorders Application site erythema	18.6% 18/97 • Number of events 23 • Adverse event data was collected for 52 weeks.	26.2% 27/103 • Number of events 38 • Adverse event data was collected for 52 weeks.	22.5% 45/200 • Number of events 61 • Adverse event data was collected for 52 weeks.
General disorders Application site pruritus	9.3% 9/97 • Number of events 9 • Adverse event data was collected for 52 weeks.	13.6% 14/103 • Number of events 14 • Adverse event data was collected for 52 weeks.	11.5% 23/200 • Number of events 23 • Adverse event data was collected for 52 weeks.
Infections and infestations Nasopharyngitis	29.9% 29/97 • Number of events 42 • Adverse event data was collected for 52 weeks.	32.0% 33/103 • Number of events 46 • Adverse event data was collected for 52 weeks.	31.0% 62/200 • Number of events 88 • Adverse event data was collected for 52 weeks.
Investigations Blood prolactin increased	2.1% 2/97 • Number of events 2 • Adverse event data was collected for 52 weeks.	11.7% 12/103 • Number of events 13 • Adverse event data was collected for 52 weeks.	7.0% 14/200 • Number of events 15 • Adverse event data was collected for 52 weeks.
Investigations Weight increased	3.1% 3/97 • Number of events 3 • Adverse event data was collected for 52 weeks.	6.8% 7/103 • Number of events 7 • Adverse event data was collected for 52 weeks.	5.0% 10/200 • Number of events 10 • Adverse event data was collected for 52 weeks.
Musculoskeletal and connective tissue disorders Back pain	8.2% 8/97 • Number of events 8 • Adverse event data was collected for 52 weeks.	4.9% 5/103 • Number of events 5 • Adverse event data was collected for 52 weeks.	6.5% 13/200 • Number of events 13 • Adverse event data was collected for 52 weeks.
Nervous system disorders Akathisia	6.2% 6/97 • Number of events 6 • Adverse event data was collected for 52 weeks.	13.6% 14/103 • Number of events 18 • Adverse event data was collected for 52 weeks.	10.0% 20/200 • Number of events 24 • Adverse event data was collected for 52 weeks.
Nervous system disorders Headache	6.2% 6/97 • Number of events 7 • Adverse event data was collected for 52 weeks.	0.97% 1/103 • Number of events 1 • Adverse event data was collected for 52 weeks.	3.5% 7/200 • Number of events 8 • Adverse event data was collected for 52 weeks.
Psychiatric disorders Schizophrenia	7.2% 7/97 • Number of events 7 • Adverse event data was collected for 52 weeks.	4.9% 5/103 • Number of events 7 • Adverse event data was collected for 52 weeks.	6.0% 12/200 • Number of events 14 • Adverse event data was collected for 52 weeks.