SchizophreniaPhase 2NCT00480571
Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder
A Phase 2 study testing BL-1020 and BL 1020 High Dose in people with Schizophrenia and Schizoaffective Disorder, run by BioLineRx, Ltd. at 2 sites in 2 countries.
Trial summary
An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- BL-1020 and BL 1020 High Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2007to Dec 2007
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 18 to 65 years of age, inclusive
- meet criteria for chronic (diagnosis established > 1 year ago) schizophrenia with adequate psychotic symptoms as demonstrated by a PANSS total score > 60
- current diagnosis of schizophrenia (disorganized type, 295.10; catatonic type, 295.20; paranoid type, 295.30; undifferentiated type, 295.90) or schizoaffective disorder (295.7) in accordance with DSM-IV
- Agree to be fully hospitalized until at least Day 14 of the study
- Females must be of non-childbearing potential: surgically sterilized (i.e. tubal ligation), have had a hysterectomy prior to the screening phase, or be post-menopausal. Females who have been post-menopausal for more than 12 months but less than 24 months must have a FSH > 40 mU/mL.
Who cannot join
- Pregnant or lactating women
- administration of clozapine within 60 days prior to Baseline
- DSM-IV diagnosis of schizophreniform disorder (295.40) or schizophrenia residual sub-type (295.60), or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder
- Severity of psychosis rated severe or higher (CGI-S 6 or 7)
- Known suicidal risk (modified ISST score>7)
- Requiring disallowed concomitant psychotropic medication following enrolment into the study
- Current evidence of clinically significant or unstable illness
- Clinically significant abnormal laboratory data (e.g. creatinine, AST or ALT greater than 3 x the upper limit of normal, TSH>10 IU) at screening, or any abnormal laboratory values that could interfere with the assessment of safety (e.g. blood cell count, etc.).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Romania1 site
Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",
Bucharest, Str Mircea Vulcǎnescu 18, 010811
About this study
Official title: An Open-label, Multi-center, 6-week, Sequential Cohort Study Designed to Determine the Safety and Tolerability of Two Dose Ranges of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-affective Disorder
An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- BL-1020, BL 1020 High Dose
- Keywords
- chronic schizophrenia or schizo-affective disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-1020Drug
BL-1020 Low Dose
BL 1020 High DoseDrug
BL 1020 High Dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BL 1020 low dose Receives: Drug: BL-1020 |
| 2 | Experimental | BL 1020 High Dose Receives: Drug: BL 1020 High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder
Measured: 6 weeks
Secondary outcomes (3)
To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose
Measured: 6 weeks
To compare the efficacy of the two dose ranges of BL-1020
Measured: 6 weeks
To determine the pharmacokinetics of BL-1020 and its metabolites
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionDec 2007
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Davidson, MD, Principal investigator, Dept. of Psychiatry, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480571
- Sponsor's protocol ID
- BL-1020 II
- Status last verified
- Aug 2007
- First submitted
- 30 May 2007
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, 6-week, Sequential Cohort Study Designed to Determine the Safety and Tolerability of Two Dose Ranges of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-affective Disorder
- ClinicalTrials.gov ID
- NCT00480571
- Acronym / sponsor ID
- BL-1020 II
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- chronic schizophrenia or schizo-affective disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 31 May 2007 (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.
An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BL-1020BL 1020 low dose |
| 2 | Experimental | Drug: BL 1020 High DoseBL 1020 High Dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- 18 to 65 years of age, inclusive
- meet criteria for chronic (diagnosis established > 1 year ago) schizophrenia with adequate psychotic symptoms as demonstrated by a PANSS total score > 60
- current diagnosis of schizophrenia (disorganized type, 295.10; catatonic type, 295.20; paranoid type, 295.30; undifferentiated type, 295.90) or schizoaffective disorder (295.7) in accordance with DSM-IV
- Agree to be fully hospitalized until at least Day 14 of the study
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- administration of clozapine within 60 days prior to Baseline
- DSM-IV diagnosis of schizophreniform disorder (295.40) or schizophrenia residual sub-type (295.60), or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder
- Severity of psychosis rated severe or higher (CGI-S 6 or 7)
- Known suicidal risk (modified ISST score>7)
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 |
|---|---|---|
| BL-1020BL-1020 Low Dose | Drug | 1 |
| BL 1020 High DoseBL 1020 High Dose | Drug | 2 |
Primary outcome
To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder
Time frame: 6 weeks
3 secondary outcomes
To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose
Time frame: 6 weeks
To compare the efficacy of the two dose ranges of BL-1020
Time frame: 6 weeks
To determine the pharmacokinetics of BL-1020 and its metabolites
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2009.
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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.
Michael Davidson, MD principal investigator
Dept. of Psychiatry, Sheba Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL-1020 and BL 1020 High Dose in people with Schizophrenia and Schizoaffective Disorder, run by BioLineRx, Ltd. at 2 sites in 2 countries.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Romania. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder (time frame: 6 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 21 Jul 2009.