Bifeprunox Extension to Extension Study in Patients With... | NCT00861497

Studies
Bifeprunox Extension to Extension Study in Patients With Schizophrenia

NCT00861497

Sponsor

H. Lundbeck A/S

Status

Terminated

Last Update Posted

Sep 16, 2013Estimated

Enrollment

11Actual

Phase

Phase 3

Conditions

Schizophrenia

Interventions

Bifeprunox

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005-000497-50	EudraCT Number

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jan 2008Actual

Completion Date

Jul 2009Actual

First Submitted Date

Mar 12, 2009

First Submission Date that Met QC Criteria

Mar 12, 2009

First Posted Date

Mar 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2013

Last Update Posted Date

Sep 16, 2013Estimated

Name	Class
Solvay Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bifeprunox	Experimental		Drug: Bifeprunox

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bifeprunox	Drug	Flexible dosage: 20, 30, or 40 mg/day	Bifeprunox

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
CGI-S		Assessments every 4 to 8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@lundbeck.com	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IT001		Brescia		25123	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C509981	bifeprunox

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided