Phase 3
N=228
A Long-Term Study of JNS007ER in Patients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01561898 ↗Enrolled (actual)
228
Serious AEs
4.4%
Results posted
Sep 2012
Primary outcome: Primary: Incidence of Adverse Events — 97.4 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paliperidone extended-release (JNS007ER) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
97.4 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) |
-13.4; -11.1; -17.2; 2.8 | — |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) |
-0.6; -0.6; -0.7; 0.1 | — |
Summary
The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients with schizophrenia over a long term period.
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with schizophrenia
- Patients who have given their own consent in writing to participate in the study
- Patients untreated with antipsychotics within 28 days before the screening test
- Patients who have completed Study JNS007ER-JPN-S31, or those who continued the study at least up to the evaluation at 2 weeks and subsequently discontinued the study due to insufficient efficacy
- Patients participating in Study JNS007ER-JPN-S31 and whose ratio of treatment to the evaluation at 2 weeks is ≥75%
Exclusion Criteria
- Patients diagnosed with a mental disease other than schizophrenia
- A total PANSS score > 120 at baseline
- Substance-related disorders
- Parkinson's disease complications
- Current or a past history of convulsive disease such as epilepsy
- Current or a past history of cerebrovascular accident
- Diabetes mellitus
- Significant hepatic or renal impairment
- Significant cardiovascular disorders
- Abnormal results of hematological examination, blood chemistry test and urinalysis at screening
- Pregnant women, breast-feeding mothers, and patients who wish pregnancy during the study period or those whose pregnancy test at screening was positive
- Contraindications to risperidone products
- Patients who discontinued Study JNS007ER-JPN-S31 due to an adverse event not related to the underlying disease
- Patients judged inadequate by the investigator to participate in the study
Data sourced from ClinicalTrials.gov (NCT01561898). 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.