Bifeprunox Extension to Extension Study in Patients With Schizophrenia

Lundbeck

Status and phase

Terminated

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Bifeprunox

Study type

Interventional

Funder types

Industry

Identifiers

NCT00861497

11051

2005-000497-50 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No 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