Phase 3
N=200
Long-term Study of DSP-5423P in Patients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02335658 ↗Enrolled (actual)
200
Serious AEs
6.0%
Results posted
Nov 2020
Primary outcome: Primary: Adverse Events and Adverse Drug Reactions, Etc. — 82; 92; 174; 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DSP-5423P (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma Co., Ltd.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events and Adverse Drug Reactions, Etc. |
82; 92; 174; 60; 77; 137 | — |
| 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 |
63.6; 67.5; -3.5; -9.2; -0.1; -3.4 | — |
Summary
The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02335658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.