NCT00861497

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 16, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

March 12, 2009

Last Update Submit

September 13, 2013

Conditions

Schizophrenia

Keywords

Open-labelFlexible-doseExtensionSafety study

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • CGI-S

    Assessments every 4 to 8 weeks

Study Arms (1)

Bifeprunox

EXPERIMENTAL
Drug: Bifeprunox

Interventions

BifeprunoxDRUG

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

Bifeprunox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IT001

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

bifeprunox

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

July 1, 2009

Last Updated

September 16, 2013

Record last verified: 2013-09

Locations

IT(1)