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Bifeprunox Extension to Extension Study in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status

Terminated

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Bifeprunox

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Open-label, Flexible-dose, Extension, Safety study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

IT001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bifeprunox

Arm Description

Outcomes

Primary Outcome Measures

Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)

Secondary Outcome Measures

CGI-S

Full Information

NCT ID

NCT00861497

First Posted

March 12, 2009

Last Updated

September 13, 2013

Sponsor

H. Lundbeck A/S

Collaborators

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00861497

Brief Title

Bifeprunox Extension to Extension Study in Patients With Schizophrenia

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Terminated

Why Stopped

The study stopped after been paused (the patients were switched in the meantime)

Study Start Date

January 2006 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

Collaborators

Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bifeprunox

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bifeprunox

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

CGI-S

Time Frame

Assessments every 4 to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Email contact via H. Lundbeck A/S

Organizational Affiliation

LundbeckClinicalTrials@lundbeck.com

Official's Role

Study Director

Facility Information:

Facility Name

IT001

City

Brescia

ZIP/Postal Code

25123

Country

Italy

12. IPD Sharing Statement

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Bifeprunox Extension to Extension Study in Patients With Schizophrenia

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