Schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: 1092mg paliperidone palmitate extended release suspension for injection (eq. 700 mg paliperidone)
Product Code: R092670
Pharmaceutical Form: Prolonged-release suspension for injection in
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue to be willing to be treated with PP6M. Note: There may be a small number of subjects who complete Study R092670PSY3015 before the R092670PSY3016 protocol is approved and implemented in that local country. These subjects may be screened and can enter Study R092670PSY3016 later, provided that: Visit 1 (Day 1) of Study R092670PSY3016 (ie, first dose of PP6M) is scheduled to occur no later than 3 months after the End-of-Study visit of R092670PSY3015, that in the interim period the subject has been treated with PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.) (PP3M is preferred) and has not experienced a relapse (per criteria in Section 9.2.4, Relapse Criteria), and the subject meets other criteria for study entry. 2. Must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or higher dose) as used during the Double-blind Phase of Study R092670PSY3015 at the time of screening for this study. 3. A woman of childbearing potential must have a negative urine pregnancy test on Day 1. 4. Use contraception consistent with local regulations for subjects participating in clinical studies. Before receiving study intervention, a woman must be either: a. Not of childbearing potential, defined as being either postmenopausal or permanently sterile, as follows: ? Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. ? Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. b. Of childbearing potential, but meeting the contraception requirements as follows: ? Practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly). Examples of highly effective contraceptives include the following: - User-independent methods: Implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system; vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention; the reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the subject). - User-dependent methods: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral and injectable. . Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies. ? Agree to remain on a highly effective method throughout the study and for at least 12 months after the last d
Exclusion criteria
Exclusion criteria: 1. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 2. Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the patient. 3. If a man, has plans to father a child while enrolled in this study or within 12 months after the last dose of study intervention. Must not, if a woman, have plans to become pregnant while enrolled in this study or within 12 months after the last dose of study intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of PP6M (700 or 1000 mg eq.) and to provide access to PP6M in subjects with schizophrenia completing the R092670PSY3015 study without relapse. ;Secondary Objective: • To assess the long-term efficacy of PP6M based on: - Overall symptom improvement and global severity of the illness - Personal and social functioning - Remission rates • To continually assess the long-term effectiveness of PP6M on the prevention of relapse by evaluating the data from R092670PSY3015 and R092670PSY3016. • To evaluate the impact of PP6M on Medical Resource Utilization;Primary end point(s): • Safety: assessed through evaluation of adverse events, mental status examination, clinical laboratory values, vital signs, physical examinations, the Abnormal Involuntary Movement Scale (AIMS), and injection site evaluations. Mandatory assessments will occur at limited time points during the study with additional assessments to be added at the discretion of the investigator if considered necessary. • Proportion of subjects who receive 1, 2, 3, or 4 PP6M injections.;Timepoint(s) of evaluation of this end point: Assessed: Every 6 months and at end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Efficacy will be assessed based on the change from open-label extension baseline on: - The Clinical Global Impression-Severity (CGI-S) scale. - The Personal and Social Performance (PSP) scale. - The proportion of subjects in remission will be assessed based on the Positive and Negative Syndrome Scale (PANSS) assessment at open-label extension baseline, Month 12, Month 24, and the End-of-Study/Early Withdrawal visit. ? Effectiveness will be assessed based on relapse, where relapse in the open-label extension is defined as one or more of the following: - Psychiatric hospitalization for schizophrenia (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject’s schizophrenic symptoms); - Emergency Department/Room/Ward visit due to a worsening of the subject’s symptoms of schizophrenia, but a psychiatric hospitalization does not occur; - The subject inflicts deliberate self-injury or exhibits violent behavior resulting in suicide, clinically significant injury to him/her self or another person, or significant property damage; - The subject has suicidal or homicidal ideation and aggressive behavior that is clinically significant (in frequency and severity) in the investigator’s judgment. Based on the Healthcare Resource Utilization Questionnaire (HRUQ). ;Timepoint(s) of evaluation of this end point: Assessed: Every 6 months and at end of trial | — |
Countries
Argentina, Hong Kong, Italy, Poland, Ukraine
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed