SchizophreniaPhase 2NCT00722176
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
A Phase 2 study testing BL-1020, BL-1020 10-30 mg and risperidone in people with Schizophrenia, run by BioLineRx, Ltd. at 1 site in United States.
Trial summary
A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- BL-1020, BL-1020 10-30 mg and risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2009
- 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, 18-65 years of age at the time of entry into the BL-1020 IIb study
- Has provided informed consent to participate in the Extension Study
- Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb
- Females must have negative serum pregnancy test, or be post-menopausal, or if fecund, must practice established methods of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]) for at least two months prior to screening
- Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication
- Has a caregiver or an identified responsible person (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with the treatment and outpatient visits
- Is willing to comply with not taking any prohibited medications during participation in the study
- Successful completion of End of Study assessments from BL-1020 IIb
Who cannot join
- Is unwilling or unable to provide informed consent
- Is unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- Has a medical condition that would put him/her at risk for continuing in the study
- Score > 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST)
- Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study BL-1020 IIb)
- Has been non-compliant with the study medication dosing and/or study procedures during the initial 6 weeks of treatment in Study BL-1020 IIb
- Is judged by the PI to be inappropriate for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92868
About this study
Official title: A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone
A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo
Read the detailed description
This is a six-week, randomized, double blind, multi-center, parallel group Extension to the BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after experiencing an acute exacerbation of schizophrenia. Patients who completed the 6 week treatment period and/or all efficacy assessments in Study BL-1020 IIb are eligible to continue double-blind treatment in this optional 6 week Extension Study. Approximately 220 patients will be enrolled in this study: Treatment Group IE (n=82, 10 mg/day BL-1020); Treatment Group IIE (n=82: target dose 30 mg/day BL-1020); Treatment Group IIIE (n=55; target dose 8 mg/day risperidone). Study drug (BL-1020 or risperidone) will be administered orally, once daily, in a doubleblinded manner, during this six-week Extension Study
- Conditions
- Schizophrenia
- Being tested
- BL-1020, BL-1020 10-30 mg, risperidone
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-1020Drug
10 mg
BL-1020 10-30 mgDrug
Also called BL-1020 High Dose
BL-1020 10-30 mg
risperidoneDrug
risperidone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BL-1020 10 mg Receives: Drug: BL-1020 |
| 2 | Experimental | BL-1020 10-30 mg Receives: Drug: BL-1020 10-30 mg |
| 3 | Active comparator | risperidone Receives: Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from baseline in vital signs, laboratory and ECG evaluations, physical/neurological examination, Extrapyramidal Symptom Rating Scale (ESRS), and incidence of adverse events (AEs) and adverse drop-outs (ADOs).
Measured: 6 weeks
Secondary outcomes (1)
Comparisons between each of the BL-1020 treatment groups and the risperidone group
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 posted25 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionDec 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mary Ann Knisevich, MD, Principal investigator, University Hills Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722176
- Sponsor's protocol ID
- BL-1020 IIb (Extension)
- Status last verified
- Jun 2010
- First submitted
- 23 Jul 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone
- ClinicalTrials.gov ID
- NCT00722176
- Acronym / sponsor ID
- BL-1020 IIb (Extension)
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jul 2008 (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.
A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo
Detailed description
This is a six-week, randomized, double blind, multi-center, parallel group Extension to the BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after experiencing an acute exacerbation of schizophrenia. Patients who completed the 6 week treatment period and/or all efficacy assessments in Study BL-1020 IIb are eligible to continue double-blind treatment in this optional 6 week Extension Study. Approximately 220 patients will be enrolled in this study: Treatment Group IE (n=82, 10 mg/day BL-1020); Treatment Group IIE (n=82: target dose 30 mg/day BL-1020); Treatment Group IIIE (n=55; target dose 8 mg/day risperidone). Study drug (BL-1020 or risperidone) will be administered orally, once daily, in a doubleblinded manner, during this six-week Extension Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BL-1020BL-1020 10 mg |
| 2 | Experimental | Drug: BL-1020 10-30 mgBL-1020 10-30 mg |
| 3 | Active comparator | Drug: risperidonerisperidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study
- Has provided informed consent to participate in the Extension Study
- Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb
- Females must have negative serum pregnancy test, or be post-menopausal, or if fecund, must practice established methods of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]) for at least two months prior to screening
- Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication
Key exclusion criteria (7 listed)
- Is unwilling or unable to provide informed consent
- Is unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- Has a medical condition that would put him/her at risk for continuing in the study
- Score > 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST)
- Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study BL-1020 IIb)
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-102010 mg | Drug | 1 |
| BL-1020 10-30 mgAlso: BL-1020 High DoseBL-1020 10-30 mg | Drug | 2 |
| risperidonerisperidone | Drug | 3 |
Primary outcome
changes from baseline in vital signs, laboratory and ECG evaluations, physical/neurological examination, Extrapyramidal Symptom Rating Scale (ESRS), and incidence of adverse events (AEs) and adverse drop-outs (ADOs).
Time frame: 6 weeks
1 secondary outcome
Comparisons between each of the BL-1020 treatment groups and the risperidone group
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 29 Jun 2010.
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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.
Mary Ann Knisevich, MD principal investigator
University Hills Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL-1020, BL-1020 10-30 mg and risperidone in people with Schizophrenia, run by BioLineRx, Ltd. at 1 site in United States.
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 8 inclusion and 7 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 29 Jun 2010. 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 United States. 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?
changes from baseline in vital signs, laboratory and ECG evaluations, physical/neurological examination, Extrapyramidal Symptom Rating Scale (ESRS), and incidence of adverse events (AEs) and adverse drop-outs (ADOs). (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 29 Jun 2010.