E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To explore the efficacy, based on total Positive and Negative Syndrome Scale PANSS score, of flexibly dosed paliperidone ER in subjects with schizophrenia previously unsuccessfully treated with other oral antipsychotics. For this purpose, 4 different groups of subjects will be distinguished based upon the main reason for transition from their previous treatment to flexibly dosed paliperidone ER lack of efficacy of the previous antipsychotic treatment; lack of tolerability or safety with the previous antipsychotic treatment; lack of compliance; other. For the group of subjects who transition for lack of efficacy, the primary objective is to investigate improved efficacy. For the other groups the primary objective is to investigate maintained efficacy. |
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E.2.2 | Secondary objectives of the trial |
To explore the tolerability and safety of flexibly dosed paliperidone ER in subjects with schizophrenia previously unsuccessfully treated with other oral antipsychotics; To explore the characteristics of response within different subgroups of the transition from previous oral antipsychotic medication to flexibly dosed paliperidone ER. This will be done by assessing efficacy by means of the Positive and Negative Syndrome Scale PANSS ; proportion of subjects improving 20 in total PANSS from baseline to endpoint; general measures of treatment success by means of the Clinical Global Impression-Severity score CGI-S ; personal and social functioning by means of the Personal and Social Performance PSP scale; health status by means of the self-rated SF-36 Health Survey; Subject satisfaction; evaluation of sleep quality and daytime drowsiness by means of a self-rated 11-point Evaluation Scale; side effect profiles. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subject meets the DSM-IV criteria for schizophrenia; Subject is previously non-acute, i.e. on the same antipsychotic medication used for the treatment of schizophrenia and CGI-S change 1 in the past 4 weeks before enrollment. Subject has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication; Male or female, aged 18 years; Subject is able to read, understand and sign the Institutional Review Board-approved informed consent form; Subject is healthy on the basis of a physical examination and vital signs at screening; Female subjects must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study. Effective methods of birth control include prescription hormonal contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patch and male partner sterilization. Female subjects must also have a negative urine pregnancy test at screening; Subjects must be willing and able to fill out self-administered questionnaires. |
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E.4 | Principal exclusion criteria |
Potential subjects who meet any of the following criteria will be excluded from participating in the study On clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months; Serious unstable medical condition, including known clinically relevant laboratory abnormalities; History or current symptoms of tardive dyskinesia; History of neuroleptic malignant syndrome; Judged to be at high risk for adverse events, violence, or self-harm; Pregnant or breast-feeding female; Participation in an investigational drug trial in the 30 days prior to selection; Known hypersensitivity to paliperidone ER or risperidone; Inability to swallow the study medication whole with the aid of water subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile ; Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator; Subjects with a current use or known history over the past 6 months of substance dependence according to DSM-IV Criteria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy criterion will be the change from baseline in total PANSS score at the end of the main study phase Week 26 or last post-baseline visit . For the group of subjects that transitioned for the main reason of lack of efficacy, improved efficacy based on the percentage of patients with 20 improvement in total PANSS will be the primary parameter. For the group of subjects that transitioned for the main reason of lack of tolerability, lack of compliance or other reason, maintained efficacy based on the change in total PANSS, will be the primary parameter |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |