Bifeprunox Extension to Extension Study in Patients With Schizophrenia

Phase 3

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Bifeprunox

• Registration Number: NCT00861497
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-01
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Study Completion: 2009-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bifeprunox	Bifeprunox	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
CGI-S	Assessments every 4 to 8 weeks

Trial Locations

Locations (1)

IT001; 🇮🇹 Brescia, Italy