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 effect of flexible doses of extended-release (ER) paliperidone in symptomatic subjects with schizophrenia with a duration of illness < 10 years by measuring the change in total PANSS score from baseline to endpoint. |
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E.2.2 | Secondary objectives of the trial |
To explore tolerability,safety,efficacy,disease severity, functioning and patients' subjective experiences and attitudes toward treatments by the following measurements: -assessing the efficacy on psychotic symptoms (Positive and Negative Syndrome Scale [PANSS] subscores); -assessing the proportion of subjects improving ≥ 30% in total PANSS score from baseline to endpoint; -assessing the patients’ subjective experience and attitude towards their illness and medication (Subjective Well-being Under Neuroleptic [SWN 20] and Drug Attitude Inventory [DAI 30]) -assessing disease severity (Clinical Global Impression–Severity Scale [CGI-S]); -assessing personal and social functioning (Personal and Social Performance Scale [PSP]); -assessing quality of sleep and daytime drowsiness (11-point categorical evaluation scale); assessing side effects profiles by means of the Extrapyramidal Symptom Rating Scale (ESRS), body weight, vital signs, physical examination and adverse events (AEs).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible to enroll in this trial, all subjects must meet all of the following criteria: Subject meets the DSM-IV criteria for schizophrenia; Male or female, between 18 and 45 years of age, inclusive; Subject must be experiencing psychotic symptoms, with a PANSS total score at screening of ≥70, ≤100; Symptomatic subject who needs to be switched from the current oral antipsychotic therapy due to insufficient efficacy on symptoms (e.g. negative, positive, general) or due to side effects; Subject is followed as outpatients; Subject is able to read, understand and sign the Institutional Review Board (IRB)-approved informed consent form; Female subjects must be postmenopausal for at least 1 year, surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator), or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, male partner sterilization before entry and throughout the study. Female subjects must also have a negative urine pregnancy test at screening; Subject must be willing and able to fill out self-administered questionnaires. |
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E.4 | Principal exclusion criteria |
Subjects who meet one or more of the following criteria cannot be selected: -Acute psychotic relapse that requires hospitalization; -First antipsychotic treatment ever; -On clozapine or a long-acting injectable antipsychotic 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; -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); -Subjects with a narrowing or blockage of their gastro-intestinal tract; -Subjects with current or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria; -Known hypersensitivity to paliperidone ER or risperidone -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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be the change in total PANSS score measured at the end of the study (Week 13 or last post-baseline evaluation) versus baseline |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 40 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |