Bifeprunox Extension to Extension Study in Patients With Schizophrenia
The purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. A further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Safety Study of Bifeprunox Investigating Flexible Doses of 20, 30, or 40mg/Day in Patients With Schizophrenia Who Have Completed Studies 10206 or 10265|
- Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS) [ Time Frame: Assessments every 4 to 8 weeks ] [ Designated as safety issue: Yes ]
- CGI-S [ Time Frame: Assessments every 4 to 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||July 2009|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Flexible dosage: 20, 30, or 40 mg/day
This is a non-controlled, open-label, flexible-dose, international multi-centre extension study. The patient population consists of male and female patients with schizophrenia, who have completed open-label bifeprunox studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.