| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 |
|
| 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 |
The primary objective of this study is to assess the observed change in the
Medication Satisfaction Questionnaire (MSQ) score, from baseline to the
Week 6 endpoint, when paliperidone ER (6 mg to 12 mg) is administered for
at least 4 weeks to subjects with schizophrenia who are suboptimally
responsive to oral risperidone 4 mg or 6 mg. |
|
| E.2.2 | Secondary objectives of the trial |
| The secondary objectives are to explore efficacy and safety outcomes in subjects treated with paliperidone ER for up to 6 weeks |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Male or female at least 18 years of age
2. Must be able to understand, in the opinion of the investigator, the informed consent form approved by the Independent Ethics Committee/Institutional Review Board (IEC/IRB). All subjects must sign the study informed consent document indicating that they understand the purpose of the study and the procedures required for the study and are willing to participate in the study. If a subject has an appointed legal representative, both the representative and the subject will sign the consent form. Subjects who are unable to provide their own consent are not eligible to enroll in the study. In addition, reasonable efforts should be made to provide information about the study to all subjects’ designated contact person.
3. Female subjects must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and a negative urine pregnancy test at screening.
4. Male subjects must be abstinent, surgically sterile, or, if sexually active, be practicing an effective method of birth control (e.g. double barrier method, or, their female partner must be surgically sterile, or using prescription oral contraceptives, contraceptive injections, contraceptive patch or have an intrauterine device) before entry and throughout the study.
5. Be diagnosed with schizophrenia according to DSM IV (295.30 paranoid type, 295.10 disorganized type, 295.90 undifferentiated type, or residual type 295.60)
6. Have scores of at least 4 ("Moderate") on at least 3 of the following symptom factors of the PANSS at the screening and baseline visits:
• G4 Tension
• G9 Unusual thought content
• P1 Delusions
• P3 Hallucinatory behavior
• P4 Excitement
• P5 Grandiosity
• P6 Suspiciousness/persecution
7. Report dissatisfaction with current medication as measured by a TSQM Item #14 score of 1 to 3 ("Extremely Dissatisfied", "Very Dissatisfied", or "Dissatisfied") at the screening and baseline visits
8. Have an aspect of disease management, which, in the investigator's opinion, could potentially benefit from a change in antipsychotic medication
9. Receive oral risperidone 4 mg or 6 mg for at least 4 weeks immediately
before randomization.
10. Willing and able, in the investigator's opinion, to remain compliant and adhere to the prohibitions and restrictions specified in this protocol
11. Be able, in the opinion of the investigator, to comply with self-administration of medication or have consistent help/support available to supervise medication administration
12. Outpatients, who in the opinion of the investigator, are likely to remain
outpatient during the course of the study (subjects who are chronically
hospitalized for purely social reasons, but otherwise meet entry criteria, may be considered for inclusion on a case-by-case bases after review by
the sponsor). |
|
| E.4 | Principal exclusion criteria |
General:
1. Inability to swallow study drug whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
2. Have received an investigational drug, used an investigational medical device, or participated in a clinical study that altered their medication within 6 months before the first administration of study drug, or have participated in more than 2 investigational drug studies within the past 12 months
3. Women who are pregnant (as confirmed by urine pregnancy test performed at baseline), planning to become pregnant, or breast-feeding
4. Any employee or family member of the Investigator, Johnson & Johnson, or the institution that has direct involvement with the trial or other trials under the direction of the Investigator or their staff members
Psychiatric History:
5. Clinical Global Impressions-Severity (CGI-S) less than 4 at the screening visit
6. DSM IV criteria for any other Axis I diagnosis with the exception of nicotine dependence (use of tobacco or products containing tobacco is permitted)
7. DSM IV criteria for substance or alcohol dependence within the past 6 months
8. Use of cocaine or heroin within 3 months before the first administration of study drug
9. Positive urine drug screen for cocaine, opiates, or amphetamines at the screening visit
10. History of neuroleptic malignant syndrome or tardive dyskinesia/dystonia
11. History of violence or, as deemed by the investigator, at imminent risk for harming others or damaging property
12. History of attempted suicide within 12 months before study entry or, as deemed by the investigator, at imminent risk of suicide or self harm
Treatment History:
13. Hospitalized for psychotic symptoms within 4 weeks before first administration of study drug
14. Hospitalized for psychotic symptoms or relapse more than 2 times within the past 6 months
15. Established treatment-refractory schizophrenia as evidenced by any of the following:
A. those who have had treatment failures or no clinical response despite adequate doses and duration of treatment with 2 antipsychotic drugs from different classes (failure to tolerate a medication does not count toward this definition), or
B. previous treatment with clozapine for established treatment-refractory schizophrenia within the past 5 years, or
C. hospitalization for psychotic symptoms for 4 or more times in the last 12 months, except for purely social reasons (e.g., food, housing, shelter, or respite care)
16. History of hypersensitivity to paliperidone or risperidone
17. Treatment history of failure to respond to risperidone or paliperidone
18. History of any of the following disallowed therapies:
A. treatment with any antipsychotic in addition to treatment with risperidone within 30 days before the baseline visit; or
B. treatment with paliperidone within 30 days before the baseline visit; or
C. treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 3 months (90 days) of the screening visit; or
D. any treatment with clozapine within the previous 60 days; or
E. treatment with carbamazepine within 60 days before the baseline visit
Medical History:
19. History of significant neurological or medical disease
20. History of seizure disorder and/or head injury
21. Evidence of clinically significant or unstable cardiovascular, gastrointestinal, neurological, endocrine, metabolic, or pulmonary disease for the past 6 months that would increase the risk associated with taking study medication or would confound the interpretation of the study
22. History or current evidence of any medical condition that could potentially alter gastrointestinal absorption (such as Crohn’s disease) or severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
23. History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including
A. heart rate less than 50 beats per minute; or
B. clinically relevant hypokalemia or hypomagnesemia; or
C. concomitant use of other drugs that prolong the QTc interval (including Class 1A [e.g., quinidine, procainamide] or Class III [e.g., amiodarone, sotalol] antiarrhythmic medications, antipsychotic medications [e.g., chlorpromazine, thioridazine], antibiotics [e.g., gatifloxacin, moxifloxacin], or any other class of medications known to prolong the QTc interval); or
D. presence of congenital prolongation of the QT interval.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary outcome measurement is the subject assessed Medication Satisfaction Questionnaire (MSQ) score. |
|
| 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 | Yes |
| 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 | Yes |
| 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 | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| 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 | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 18 |
| 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 |
|
| 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
|
| The study is considered completed with the last visit of the last subject undergoing the study. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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