Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BL-1020
BL-1020 10-30 mg
risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of California, Irvine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
BL-1020 10 mg
BL-1020 10-30 mg
risperidone
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Comparisons between each of the BL-1020 treatment groups and the risperidone group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00722176
Brief Title
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
BioLineRx, Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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), 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
BL-1020 10 mg
Arm Title
2
Arm Type
Experimental
Arm Description
BL-1020 10-30 mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
risperidone
Intervention Type
Drug
Intervention Name(s)
BL-1020
Intervention Description
10 mg
Intervention Type
Drug
Intervention Name(s)
BL-1020 10-30 mg
Other Intervention Name(s)
BL-1020 High Dose
Intervention Description
BL-1020 10-30 mg
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Description
risperidone
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Comparisons between each of the BL-1020 treatment groups and the risperidone group
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Ann Knisevich, MD
Organizational Affiliation
University Hills Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
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