MedDataX Logo

Bifeprunox Extension to Extension Study in Patients With Schizophrenia

NCT ID: NCT00861497

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Open-label Flexible-dose Extension Safety study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bifeprunox

Group Type EXPERIMENTAL

Bifeprunox

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bifeprunox

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Solvay Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IT001

Brescia, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2005-000497-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11051

Identifier Type: -

Identifier Source: org_study_id