A Trial to Explore the Tolerability, Safety and Treatment Response of the Antipsychotic Paliperidone ER (Extended Release) Using Flexible Dosing in Patients With Acute Schizophrenia
The purpose of this study is to explore the tolerability, safety and treatment response of flexibly dosed paliperidone ER in patients with schizophrenia who are admitted for an acute exacerbation of their disease.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia|
- The primary efficacy variable is treatment response, which is defined as a decrease of at least 30% in total Positive and Negative Syndrome Scale (PANSS) score from baseline to endpoint.
- The secondary objectives are to explore effectiveness, tolerability and safety as measured by disease severity, functioning, and treatment satisfaction.
|Study Start Date:||June 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
This trial is an open-label, single arm, multicenter 6-week study which is aimed to explore tolerability, safety and effectiveness of flexibly dosed paliperidone ER in patients with schizophrenia who are admitted for an acute exacerbation of their disease. Hospitalization is mandatory for the first 7 days of the study. Patients who complete this 6-week study, responded and would like to continue treatment, will receive paliperidone ER, during an extension phase. This extension phase will last until the drug is approved and reimbursed in the respective country, or earlier, in case the sponsor would decide to stop the development and/or the registration of the product. In any case, the extension phase will last no longer than 12 months after the last subject has completed the 6-week core treatment phase of the study.
The primary aim of this study is to explore the treatment response to flexible doses of extended-release (ER) paliperidone in acutely exacerbated patients with schizophrenia. Response is defined as a decrease of at least 30% in total Positive and Negative Syndrome Scale (PANSS) score from baseline to endpoint.
The secondary objectives are to explore effectiveness, tolerability, safety, disease severity, functioning, and treatment satisfaction through the following.
Assessing the effectiveness on psychotic symptoms by Positive and Negative Syndrome Scale [PANSS] total score and subscores, the proportion of subjects improving >= 20%, >= 40% and >= 50% in total PANSS from baseline to endpoint and exploring the onset of efficacy of flexible doses of paliperidone ER (as measured by individual subject's change in total PANSS score between study visits).
Evaluation of the disease severity by Clinical Global Impression-Severity Scale [CGI-S], the personal and social functioning by Personal and Social Performance Scale [PSP], the quality of sleep and daytime drowsiness by a 11-point categorical evaluation scale and patients' treatment satisfaction by a 5-point categorical evaluation scale; Assessing the safety and tolerability for extrapyramidal symptoms by Abnormal Involuntary Movement Scale [AIMS]; Simpson-Angus Extrapyramidal Symptoms Rating Scale [SAS], and Barnes Akathisia Rating Scale [BARS]) and for side effect profiles by means of physical examination, body weight, vital signs and adverse events (AEs).
In general, the recommended paliperidone ER dose will be 6 mg once daily. Some patients may benefit from higher or lower doses in the recommended range of 3 to 12 mg once daily. Patients from any oral antipsychotic medication can be transitioned to an effective dose of paliperidone ER without the need for titration. There will be 4 dosage levels of paliperidone ER (3, 6, 9, and 12 mg). Throughout the study flexible dosing in a range of 3 to 12 mg/day may be used. Adjustment of the dosage will be done at the investigators' discretion, based on the individual patient's clinical response to and tolerability of the study drug. Patients who complete this 6-week core study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available.