SchizophreniaPhase 3NCT00861497
Bifeprunox Extension to Extension Study in Patients With Schizophrenia
A Phase 3 study testing Bifeprunox in people with Schizophrenia, run by H. Lundbeck A/S at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Bifeprunox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Bifeprunox
- Keywords
- Open-label, Flexible-dose, Extension, Safety study
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BifeprunoxDrug
Flexible dosage: 20, 30, or 40 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Bifeprunox | Experimental | Not described Receives: Drug: Bifeprunox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)
Measured: Assessments every 4 to 8 weeks
Secondary outcomes (1)
CGI-S
Measured: Assessments every 4 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionJul 2009
Why it stopped: The study stopped after been paused (the patients were switched in the meantime)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861497
- Sponsor's protocol ID
- 11051
- Other IDs
- 2005-000497-50, 2005
- Status last verified
- Sep 2013
- First submitted
- 12 Mar 2009
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00861497
- Acronym / sponsor ID
- 11051
- Conditions
- Schizophrenia
- Keywords
- Open-label, Flexible-dose, Extension, Safety study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped after been paused (the patients were switched in the meantime)
- Enrolment
- 11 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bifeprunox | Experimental | Drug: Bifeprunox |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BifeprunoxFlexible dosage: 20, 30, or 40 mg/day | Drug | Bifeprunox |
Primary outcome
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
1 secondary outcome
CGI-S
Time frame: Assessments every 4 to 8 weeks
Results and safety
The study was stopped early (reason given: The study stopped after been paused (the patients were switched in the meantime)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bifeprunox in people with Schizophrenia, run by H. Lundbeck A/S at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study stopped after been paused (the patients were switched in the meantime)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.