Bifeprunox Extension to Extension Study in Patients With Schizophrenia

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00861497

Enrollment

Registered

2009-03-13

Start date

2006-01-31

Completion date

2009-07-31

Last updated

2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Open-label, Flexible-dose, Extension, Safety study

Brief summary

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.

Detailed description

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.

Interventions

DRUGBifeprunox

Flexible dosage: 20, 30, or 40 mg/day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients, suffering from schizophrenia, having completed studies 10206 or 10265 * Otherwise healthy * Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women using adequate contraception * The patient must be in need of treatment with bifeprunox (that is, the switch to another compound is not feasible)

Exclusion criteria

* Current Axis I primary psychiatric diagnosis other than schizophrenia * Significant risk of suicide and/or violent behaviour * Other psychiatric, neurological or behavioural disorders that may interfere with study conduct * Substance or alcohol abuse, current cannabis dependence * Clinically significant physical illness

Design outcomes

Primary

Measure	Time frame
Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)	Assessments every 4 to 8 weeks

Secondary

Measure	Time frame
CGI-S	Assessments every 4 to 8 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026