SchizophreniaPhase 3NCT02335658

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

A Phase 3 study testing DSP-5423P in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study evaluates the long term safety of DSP-5423P in patients with schizophrenia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Schizophrenia
What is being tested?: DSP-5423P
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteJapan
Study dates: Dec 2014to May 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Patients who fall under a contraindication listed in the LONASEN® package insert
Patients with Parkinson disease, etc.

Trial locations and contacts

1 site in 1 country.

Japan1 site

38 Sites
Tokyo

Other trials in Japan

About this study

Official title: Long-term Study of DSP-5423P in Patients With Schizophrenia <Phase 3>

The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.

Conditions: Schizophrenia
Being tested: DSP-5423P
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DSP-5423PDrug
40-80mg/day

Study groups in NCT02335658
Study group	Role	What they receive
DSP-5423P	Experimental	Percutaneous Receives: Drug: DSP-5423P

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Week 52, Week 52 (LOCF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014May 2017

First posted12 Jan 2015 (estimated)
Study startDec 2014
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02335658
Sponsor's protocol ID: D4904040
Other IDs: JapicCTI-152765
Status last verified: Apr 2022
First submitted: 7 Jan 2015
Last updated: 12 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 31883082

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Study of DSP-5423P in Patients With Schizophrenia <Phase 3>
ClinicalTrials.gov ID: NCT02335658
Acronym / sponsor ID: D4904040
Conditions: Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 12 Jan 2015 (estimated)
Results: Posted 19 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DSP-5423P	Experimental	Drug: DSP-5423PPercutaneous

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

Patients who fall under a contraindication listed in the LONASEN® package insert
Patients with Parkinson disease, etc.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DSP-5423P40-80mg/day	Drug	DSP-5423P

Primary outcome

Adverse Events and Adverse Drug Reactions, Etc.
Time frame: 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.

1 secondary outcome

Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline
Time frame: Week 52, Week 52 (LOCF)

Results and safety

Results posted to the registry on 19 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DSP-5423P (Cohort 1)	97	57
DSP-5423P (Cohort 2)	103	59

Primary outcome: Adverse Events and Adverse Drug Reactions, Etc.

Time frame: week 52. Count of participants. Unit: Participants

Measure	DSP-5423P (Cohort 1) n = 97	DSP-5423P (Cohort 2) n = 103	DSP-5423P (Overall) n = 200
Subjects with any AE	82	92	174
Subjects with any treatment-related ADR	60	77	137

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for 52 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DSP-5423P (Cohort 1)	6 of 97 (6.2%)	82 of 97 (84.5%)	0 of 97
DSP-5423P (Cohort 2)	6 of 103 (5.8%)	92 of 103 (89.3%)	0 of 103
DSP-5423P (Overall)	12 of 200 (6%)	174 of 200 (87%)	0 of 200

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31883082Iwata 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.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Director, Drug Development Division study director

Sumitomo Pharma Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DSP-5423P in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events and Adverse Drug Reactions, Etc. (time frame: week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02335658, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.